NCT00111800 is a Phase 2 clinical trial of DEN 2.5 mg in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00111800?

NCT00111800 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00111800?

Interventions in NCT00111800: Placebo, DEN 2.5 mg, DEN 7.5 mg, DEN 15 mg, DEN 30 mg, DEN 45 mg.

What condition does NCT00111800 study?

NCT00111800 studies Diabetes Mellitus, Type 2.

Is NCT00111800 still recruiting?

NCT00111800 is currently completed. Last updated 21 March 2018.

Are results published for NCT00111800?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-21 · How we verify

NCT00111800

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A New Oral Treatment For Type II Diabetes Mellitus

Completed Phase 2 Results posted Last updated 21 March 2018

What this trial tests

Phase 2 trial testing Placebo in Diabetes Mellitus, Type 2 in 375 participants. Completed in 21 July 2006.

Timeline

28 April 2005

Primary endpoint
1 July 2006

21 July 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	375
Start date	28 April 2005
Primary completion	1 July 2006
Estimated completion	21 July 2006
Sites	109 locations across Finland, Greece, Sweden, Germany, Romania, Canada, Puerto Rico, Latvia

Drugs / interventions tested

Placebo
DEN 2.5 mg — full drug profile →
DEN 7.5 mg — full drug profile →
DEN 15 mg — full drug profile →
DEN 30 mg — full drug profile →
DEN 45 mg — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 Primary · Baseline (Week 0) and Week 12

HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monot

Group	Value	95% CI
Placebo	0.46	± 0.105
DEN 2.5 mg	0.18	± 0.107
DEN 7.5 mg	-0.07	± 0.104
DEN 15 mg	0.01	± 0.102
DEN 30 mg	-0.34	± 0.107
DEN 45 mg	-0.38	± 0.105

Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24 Secondary · Baseline (Week 0) up to Week 24

HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values.

Week 4

Group	Value	95% CI
Placebo	0.22	± 0.672
DEN 2.5 mg	-0.01	± 0.505
DEN 7.5 mg	-0.11	± 0.586
DEN 15 mg	-0.05	± 0.474
DEN 30 mg	-0.25	± 0.436
DEN 45 mg	-0.32	± 0.445

Week 8

Group	Value	95% CI
Placebo	0.21	± 1.019
DEN 2.5 mg	0.13	± 0.753
DEN 7.5 mg	-0.04	± 0.789
DEN 15 mg	-0.04	± 0.645
DEN 30 mg	-0.36	± 0.653
DEN 45 mg	-0.41	± 0.579

Week 16

Group	Value	95% CI
Placebo	0.40	± 1.146
DEN 2.5 mg	0.14	± 0.934
DEN 7.5 mg	-0.04	± 0.926
DEN 15 mg	0.05	± 0.790
DEN 30 mg	-0.30	± 0.968
DEN 45 mg	-0.36	± 0.821

Week 20

Group	Value	95% CI
Placebo	0.31	± 1.171
DEN 2.5 mg	0.22	± 1.143
DEN 7.5 mg	0.02	± 1.032
DEN 15 mg	0.12	± 0.853
DEN 30 mg	-0.25	± 0.960
DEN 45 mg	-0.35	± 0.823

Week 24

Group	Value	95% CI
Placebo	0.35	± 1.252
DEN 2.5 mg	0.21	± 1.184
DEN 7.5 mg	0.06	± 1.095
DEN 15 mg	0.16	± 0.942
DEN 30 mg	-0.28	± 0.994
DEN 45 mg	-0.30	± 0.900

Change From Baseline in FPG at Week 12 Secondary · Baseline (Week 0) and Week 12

The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate)

Group	Value	95% CI
Placebo	0.52	± 0.273
DEN 2.5 mg	0.11	± 0.282
DEN 7.5 mg	-0.28	± 0.272
DEN 15 mg	-0.07	± 0.270
DEN 30 mg	-0.95	± 0.281
DEN 45 mg	-0.71	± 0.276

Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24 Secondary · Baseline (Week 0) up to Week 24

The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-

Week 1

Group	Value	95% CI
Placebo	0.33	± 1.247
DEN 2.5 mg	0.18	± 2.178
DEN 7.5 mg	-0.45	± 1.462
DEN 15 mg	-0.11	± 1.782
DEN 30 mg	-0.73	± 1.088
DEN 45 mg	-0.71	± 1.605

Week 2

Group	Value	95% CI
Placebo	0.35	± 1.385
DEN 2.5 mg	0.23	± 2.113
DEN 7.5 mg	-0.30	± 1.575
DEN 15 mg	-0.25	± 1.460
DEN 30 mg	-0.66	± 1.514
DEN 45 mg	-0.69	± 2.043

Week 3

Group	Value	95% CI
Placebo	0.37	± 1.442
DEN 2.5 mg	0.19	± 1.975
DEN 7.5 mg	-0.65	± 1.814
DEN 15 mg	-0.28	± 1.603
DEN 30 mg	-0.81	± 1.591
DEN 45 mg	-0.89	± 1.844

Week 4

Group	Value	95% CI
Placebo	0.16	± 1.595
DEN 2.5 mg	0.22	± 2.005
DEN 7.5 mg	-0.52	± 2.235
DEN 15 mg	-0.43	± 1.548
DEN 30 mg	-1.21	± 1.514
DEN 45 mg	-1.31	± 1.764

Week 6

Group	Value	95% CI
Placebo	0.17	± 1.507
DEN 2.5 mg	0.21	± 2.149
DEN 7.5 mg	-0.61	± 2.139
DEN 15 mg	-0.28	± 1.420
DEN 30 mg	-1.02	± 1.657
DEN 45 mg	-0.81	± 1.882

Week 8

Group	Value	95% CI
Placebo	0.39	± 1.745
DEN 2.5 mg	0.18	± 1.996
DEN 7.5 mg	-0.50	± 2.235
DEN 15 mg	-0.33	± 1.593
DEN 30 mg	-0.86	± 1.869
DEN 45 mg	-1.10	± 1.801

Week 13

Group	Value	95% CI
Placebo	0.25	± 2.228
DEN 2.5 mg	0.28	± 2.305
DEN 7.5 mg	-0.19	± 2.226
DEN 15 mg	-0.21	± 2.016
DEN 30 mg	-0.84	± 2.175
DEN 45 mg	-0.96	± 2.058

Week 14

Group	Value	95% CI
Placebo	0.34	± 2.348
DEN 2.5 mg	0.31	± 2.444
DEN 7.5 mg	-0.35	± 2.492
DEN 15 mg	-0.11	± 1.821
DEN 30 mg	-0.73	± 2.279
DEN 45 mg	-0.86	± 2.087

Number of Participants Who Were HbA1c Responders at Week 12 Secondary · Week 12

HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of \<=6.5%, \<7% and HbA1c reduction of \>=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.

HbA1c <=6.5%

Group	Value	95% CI
Placebo	6
DEN 2.5 mg	4
DEN 7.5 mg	4
DEN 15 mg	5
DEN 30 mg	9
DEN 45 mg	8

HbA1c <7%

Group	Value	95% CI
Placebo	11
DEN 2.5 mg	9
DEN 7.5 mg	12
DEN 15 mg	9
DEN 30 mg	14
DEN 45 mg	14

HbA1c reduction >=0.7%

Group	Value	95% CI
Placebo	10
DEN 2.5 mg	6
DEN 7.5 mg	14
DEN 15 mg	10
DEN 30 mg	21
DEN 45 mg	17

Number of Participants of FPG Responders at Week 12 Secondary · Week 12

The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of \<7 mmol/L and FPG reduction value of \>=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.

FPG <7 mmol/L

Group	Value	95% CI
Placebo	5
DEN 2.5 mg	8
DEN 7.5 mg	9
DEN 15 mg	4
DEN 30 mg	6
DEN 45 mg	9

FPG reduction >=1.7 mmol/L

Group	Value	95% CI
Placebo	8
DEN 2.5 mg	12
DEN 7.5 mg	13
DEN 15 mg	10
DEN 30 mg	18
DEN 45 mg	18

Change From Baseline in Fructosamine at Week 12 Secondary · Baseline (Week 0) and Week 12

The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Group	Value	95% CI
Placebo	19.9	± 5.44
DEN 2.5 mg	5.0	± 5.55
DEN 7.5 mg	-2.5	± 5.16
DEN 15 mg	-9.3	± 5.12
DEN 30 mg	-19.7	± 5.34
DEN 45 mg	-19.0	± 5.29

Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24 Secondary · Baseline (Week 0) up to Week 24

The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.

Week 4

Group	Value	95% CI
Placebo	10.3	± 38.09
DEN 2.5 mg	-4.3	± 37.01
DEN 7.5 mg	-2.9	± 34.08
DEN 15 mg	-10.1	± 33.64
DEN 30 mg	-14.8	± 29.36
DEN 45 mg	-22.0	± 36.58

Week 8

Group	Value	95% CI
Placebo	15.9	± 49.33
DEN 2.5 mg	-2.1	± 39.42
DEN 7.5 mg	-5.0	± 31.93
DEN 15 mg	-7.7	± 32.84
DEN 30 mg	-20.2	± 34.06
DEN 45 mg	-23.6	± 33.32

Week 16

Group	Value	95% CI
Placebo	8.2	± 48.67
DEN 2.5 mg	-0.5	± 48.06
DEN 7.5 mg	-3.0	± 39.37
DEN 15 mg	-3.5	± 45.02
DEN 30 mg	-12.8	± 43.62
DEN 45 mg	-18.6	± 39.53

Week 20

Group	Value	95% CI
Placebo	14.7	± 54.10
DEN 2.5 mg	3.3	± 51.12
DEN 7.5 mg	0.3	± 39.36
DEN 15 mg	-2.0	± 46.96
DEN 30 mg	-9.6	± 47.49
DEN 45 mg	-17.3	± 42.07

Week 24

Group	Value	95% CI
Placebo	11.6	± 56.07
DEN 2.5 mg	6.7	± 53.75
DEN 7.5 mg	7.1	± 49.03
DEN 15 mg	7.0	± 47.77
DEN 30 mg	-11.0	± 48.02
DEN 45 mg	-10.9	± 41.81

Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12 Secondary · Baseline (Week 0) and Week 12

The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement

Fasting serum insulin

Group	Value	95% CI
Placebo	-2.04	± 8.514
DEN 2.5 mg	-10.55	± 8.804
DEN 7.5 mg	12.14	± 8.355
DEN 15 mg	5.27	± 8.057
DEN 30 mg	3.23	± 8.732
DEN 45 mg	10.70	± 8.641

Pro-insulin

Group	Value	95% CI
Placebo	-4.28	± 2.332
DEN 2.5 mg	-0.97	± 2.418
DEN 7.5 mg	-1.21	± 2.248
DEN 15 mg	-4.63	± 2.228
DEN 30 mg	-6.49	± 2.348
DEN 45 mg	-1.53	± 2.307

Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8 Secondary · Baseline (Week 0) up to Week 24

The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week

Week 4, Fasting serum insulin

Group	Value	95% CI
Placebo	5.97	± 50.769
DEN 2.5 mg	-3.83	± 86.792
DEN 7.5 mg	2.85	± 75.790
DEN 15 mg	1.67	± 55.221
DEN 30 mg	21.80	± 78.596
DEN 45 mg	7.23	± 96.413

Week 8, Fasting serum insulin

Group	Value	95% CI
Placebo	1.10	± 42.239
DEN 2.5 mg	-11.90	± 81.300
DEN 7.5 mg	5.12	± 81.860
DEN 15 mg	2.29	± 44.507
DEN 30 mg	24.27	± 72.846
DEN 45 mg	25.21	± 246.250

Week 16, Fasting serum insulin

Group	Value	95% CI
Placebo	3.96	± 55.879
DEN 2.5 mg	-9.02	± 87.664
DEN 7.5 mg	20.68	± 148.343
DEN 15 mg	1.05	± 56.293
DEN 30 mg	11.11	± 33.429
DEN 45 mg	9.83	± 108.783

Week 20, Fasting serum insulin

Group	Value	95% CI
Placebo	9.89	± 73.956
DEN 2.5 mg	-0.65	± 96.114
DEN 7.5 mg	22.79	± 148.597
DEN 15 mg	4.76	± 57.217
DEN 30 mg	11.56	± 41.611
DEN 45 mg	0.68	± 50.704

Week 24, Fasting serum insulin

Group	Value	95% CI
Placebo	6.35	± 55.319
DEN 2.5 mg	-6.66	± 85.054
DEN 7.5 mg	23.47	± 157.791
DEN 15 mg	11.62	± 73.917
DEN 30 mg	8.07	± 36.118
DEN 45 mg	0.69	± 61.090

Week 4, Pro-insulin

Group	Value	95% CI
Placebo	-1.36	± 21.662
DEN 2.5 mg	-2.42	± 15.774
DEN 7.5 mg	-1.38	± 24.872
DEN 15 mg	-4.48	± 19.604
DEN 30 mg	-4.33	± 18.011
DEN 45 mg	-5.55	± 20.885

Week 8, Pro-insulin

Group	Value	95% CI
Placebo	0.00	± 18.948
DEN 2.5 mg	-4.23	± 16.204
DEN 7.5 mg	-3.48	± 16.865
DEN 15 mg	-4.59	± 18.539
DEN 30 mg	-3.88	± 18.139
DEN 45 mg	-4.45	± 26.313

Change From Baseline in Pro-insulin at Week 16, 20 and 24. Secondary · Baseline (Week 0) up to Week 24

The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.

Week 16

Group	Value	95% CI
Placebo	-2.32	± 19.820
DEN 2.5 mg	-4.45	± 20.161
DEN 7.5 mg	-3.27	± 16.672
DEN 15 mg	-4.24	± 25.786
DEN 30 mg	-4.67	± 13.882
DEN 45 mg	-1.35	± 33.282

Week 20

Group	Value	95% CI
Placebo	-2.52	± 11.898
DEN 2.5 mg	1.11	± 26.455
DEN 7.5 mg	-2.24	± 17.156
DEN 15 mg	-4.95	± 17.947
DEN 30 mg	-4.84	± 20.063
DEN 45 mg	-2.23	± 22.270

Week 24

Group	Value	95% CI
Placebo	-3.61	± 15.914
DEN 2.5 mg	-0.64	± 21.485
DEN 7.5 mg	-0.65	± 31.694
DEN 15 mg	-3.07	± 23.950
DEN 30 mg	-4.47	± 20.598
DEN 45 mg	-2.34	± 22.484

Change From Baseline in Pro-insulin to Insulin Ratio at Week 12 Secondary · Baseline (Week 0) and Week 12

The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.

Group	Value	95% CI
Placebo	-0.02	± 0.018
DEN 2.5 mg	0.01	± 0.019
DEN 7.5 mg	-0.04	± 0.018
DEN 15 mg	-0.06	± 0.017
DEN 30 mg	-0.08	± 0.018
DEN 45 mg	-0.06	± 0.018

Adverse events — posted to ClinicalTrials.gov

Time frame: AE's were collected up to Follow-up (up to Week 25). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/64 (2%)

Deaths: 0/64

DEN 2.5 mg

Serious: 1/61 (2%)

Deaths: 0/61

DEN 7.5 mg

Serious: 2/63 (3%)

Deaths: 0/63

DEN 15 mg

Serious: 0/66 (0%)

Deaths: 0/66

DEN 30 mg

Serious: 4/60 (7%)

Deaths: 0/60

DEN 45 mg

Serious: 3/61 (5%)

Deaths: 0/61

Serious adverse events (11 terms)

Reaction	System	Placebo	DEN 2.5 mg	DEN 7.5 mg	DEN 15 mg	DEN 30 mg	DEN 45 mg
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—
Hemiparesis	Nervous system disorders	—	—	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—
Diverticular perforation	Gastrointestinal disorders	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Placebo	DEN 2.5 mg	DEN 7.5 mg	DEN 15 mg	DEN 30 mg	DEN 45 mg
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Gastroenteritis, Laryngitis, Sepsis, Cerebrovascular accident, Hemiparesis, Ischaemic stroke, Acute myocardial infarction, Cardiac failure congestive.

Data from ClinicalTrials.gov NCT00111800 adverse events section.

Sponsor's own description

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00111800 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 21 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00111800.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00111800

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetes Mellitus, Type 2

Other GlaxoSmithKline trials

Verify against primary sources