Who is sponsoring NCT03092752?

NCT03092752 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03092752?

Interventions in NCT03092752: oral antidiabetic drugs.

What condition does NCT03092752 study?

NCT03092752 studies Diabetes Mellitus, Type 2.

Is NCT03092752 still recruiting?

NCT03092752 is currently completed. Last updated 5 July 2019.

Are results published for NCT03092752?

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

Last reviewed 2019-07-05 · How we verify

NCT03092752

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

Clinical Characteristics and Practice Patterns of Type 2 Diabetes Mellitus Patients Treated With OADs in Japan: Analysis of Medical and Health Care Database of the MDV

Completed Results posted Last updated 5 July 2019

What this trial tests

trial testing oral antidiabetic drugs in Diabetes Mellitus, Type 2 in 162,116 participants. Completed in 1 March 2017.

Timeline

1 March 2017

Primary endpoint
1 March 2017

1 March 2017

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	162,116
Start date	1 March 2017
Primary completion	1 March 2017
Estimated completion	1 March 2017
Sites	1 location across Japan

Drugs / interventions tested

oral antidiabetic drugs — full drug profile →

Conditions studied

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

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

40 and older, 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.

Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages Secondary · Within 6 months from index date

This outcome observes number of index dates for each class of OAD as per RI classes. RI classes were defined based on eGFR values. Results observed were based on index dates used for comparing drugs between the classes.

DPP4 inhibitors

Group	Value	95% CI
Group G1	1592
Group G2	4877
Group G3	3566
Group G4+	1411
Total	11446

Biguanides (BG)

Group	Value	95% CI
Group G1	838
Group G2	2373
Group G3	1045
Group G4+	67
Total	4323

Sulfonylurea (SU)

Group	Value	95% CI
Group G1	530
Group G2	1446
Group G3	1090
Group G4+	208
Total	3274

α-glucosidase (AGI)

Group	Value	95% CI
Group G1	429
Group G2	1175
Group G3	1055
Group G4+	488
Total	3147

Glinide

Group	Value	95% CI
Group G1	252
Group G2	691
Group G3	610
Group G4+	337
Total	1890

Thiazolidinedione (TZD)

Group	Value	95% CI
Group G1	227
Group G2	626
Group G3	410
Group G4+	43
Total	1306

Number of Index Dates Primary · From 1st January 2014 to 30th September 2016 (At index date)

The date at which patients having their first prescription for any study drugs between 1st January 2014 and 30th September 2016 is defined as index date. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.

Dipeptidyl-peptidase 4 inhibitor (DPP4i)

Group	Value	95% CI
Oral Antibiotic Drugs	91634

Biguanides (BG)

Group	Value	95% CI
Oral Antibiotic Drugs	33238

Sulfonylurea (SU)

Group	Value	95% CI
Oral Antibiotic Drugs	28211

α-glucosidase (AGI)

Group	Value	95% CI
Oral Antibiotic Drugs	26192

Glinide

Group	Value	95% CI
Oral Antibiotic Drugs	16787

Thiazolidinedione (TZD)

Group	Value	95% CI
Oral Antibiotic Drugs	10344

Age (Years) Primary · From 1st January 2014 to 30th September 2016 (At index date)

Age of all patients in years calculated for index dates computed from patients in the database. Analysis was done based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	71.6	± 11
Biguanides (BG)	66.5	± 11
Sulfonylurea (SU)	72	± 11.1
α-glucosidase (AGI)	71.4	± 10.8
Glinide	71.4	± 10.8
Thiazolidinedione (TZD)	69.7	± 11.4
Total	70.7	± 11.2

Sex (Male/Female) Primary · From 1st January 2014 to 30th September 2016 (At index date)

Gender of all patients observed for index dates computed from patients in the database. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.

Female

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	36018
Biguanides (BG)	12681
Sulfonylurea (SU)	10940
α-glucosidase (AGI)	9951
Glinide	6549
Thiazolidinedione (TZD)	3854
Total	79993

Male

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	55616
Biguanides (BG)	20557
Sulfonylurea (SU)	17271
α-glucosidase (AGI)	16241
Glinide	10238
Thiazolidinedione (TZD)	6490
Total	126413

Estimated Glomerular Filtration Rate (eGFR) Primary · Within 6 months from index date

Estimated glomerular filtration rate (eGFR) was calculated based on the age at index date and the latest serum creatinine at index date (or during the observation period) using formula eGFR millilitre/minute/1.73 meter\^2 (mL/min/1.73 m\^2) = 194 × (Creatinine)\^-1.094 × (age in year)\^-0.287 (× 0.739 if female). Analysis was done based on index dates used for comparing drugs between the classes.

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	63	± 28.8
Biguanides (BG)	74	± 23.9
Sulfonylurea (SU)	67.4	± 26.4
α-glucosidase (AGI)	60.1	± 29.4
Glinide	59.5	± 30.2
Thiazolidinedione (TZD)	69.7	± 23.7
Total	65.2	± 28.1

Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level Primary · Within 6 months from index date

Renal impairment (RI) is a common complication in patients with type 2 diabetes mellitus (T2DM). Results observed were based on index dates used for comparing drugs between the classes.

90 < eGFR

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	1592
Biguanides (BG)	838
Sulfonylurea (SU)	530
α-glucosidase (AGI)	429
Glinide	252
Thiazolidinedione (TZD)	227
Total	3868

60 < eGFR < 90

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	4877
Biguanides (BG)	2373
Sulfonylurea (SU)	1446
α-glucosidase (AGI)	1175
Glinide	691
Thiazolidinedione (TZD)	626
Total	11188

30 < eGFR < 60

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	3566
Biguanides (BG)	1045
Sulfonylurea (SU)	1090
α-glucosidase (AGI)	1055
Glinide	610
Thiazolidinedione (TZD)	410
Total	7776

eGFR < 30

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	1411
Biguanides (BG)	67
Sulfonylurea (SU)	208
α-glucosidase (AGI)	488
Glinide	337
Thiazolidinedione (TZD)	43
Total	2554

Percentage of Concomitant Medications by OAD Classes Primary · On the index month

Concomitant medication is the drug prescribed other than drug under study in the OAD class on index date. Results observed were based on index dates used for comparing drugs between the classes.

Use of DPP-4 inhibitors (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	3
Biguanides (BG)	40
Sulfonylurea (SU)	32
α-glucosidase (AGI)	37
Glinide	56
Thiazolidinedione (TZD)	34
Total	23

Use of Biguanides (BG) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	9
Biguanides (BG)	0
Sulfonylurea (SU)	11
α-glucosidase (AGI)	12
Glinide	20
Thiazolidinedione (TZD)	19
Total	10

Use of Sulfonylurea (SU) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	9
Biguanides (BG)	17
Sulfonylurea (SU)	1
α-glucosidase (AGI)	13
Glinide	4
Thiazolidinedione (TZD)	21
Total	10

Use of α-glucosidase (AGI) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	8
Biguanides (BG)	9
Sulfonylurea (SU)	6
α-glucosidase (AGI)	2
Glinide	16
Thiazolidinedione (TZD)	10
Total	8

Use of Glinide (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	2
Biguanides (BG)	3
Sulfonylurea (SU)	1
α-glucosidase (AGI)	4
Glinide	4
Thiazolidinedione (TZD)	4
Total	3

Use of Thiazolidinedione (TZD) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	2
Biguanides (BG)	4
Sulfonylurea (SU)	2
α-glucosidase (AGI)	3
Glinide	6
Thiazolidinedione (TZD)	1
Total	3

Use of Insulin (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	27
Biguanides (BG)	23
Sulfonylurea (SU)	25
α-glucosidase (AGI)	31
Glinide	37
Thiazolidinedione (TZD)	24
Total	27

Percentage of Previous Medications (Premedications) by OAD Classes. Primary · On the index month

Previous medication is the drug prescribed other than drug under study in the OAD class before index date. Results observed were based on index dates used for comparing drugs between the classes

Use of DPP4 inhibitors (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	0
Biguanides (BG)	3
Sulfonylurea (SU)	2
α-glucosidase (AGI)	1
Glinide	3
Thiazolidinedione (TZD)	8
Total	1

Use of Biguanides (BG) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	2
Biguanides (BG)	0
Sulfonylurea (SU)	1
α-glucosidase (AGI)	2
Glinide	3
Thiazolidinedione (TZD)	2
Total	1

Use of Sulfonylurea (SU) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	3
Biguanides (BG)	2
Sulfonylurea (SU)	0
α-glucosidase (AGI)	3
Glinide	19
Thiazolidinedione (TZD)	2
Total	4

Use of α-glucosidase (AGI) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	2
Biguanides (BG)	2
Sulfonylurea (SU)	1
α-glucosidase (AGI)	0
Glinide	8
Thiazolidinedione (TZD)	1
Total	2

Use of Glinide (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	1
Biguanides (BG)	1
Sulfonylurea (SU)	3
α-glucosidase (AGI)	2
Glinide	0
Thiazolidinedione (TZD)	0
Total	1

Use of Thiazolidinedione (TZD) (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	2
Biguanides (BG)	2
Sulfonylurea (SU)	1
α-glucosidase (AGI)	1
Glinide	1
Thiazolidinedione (TZD)	0
Total	1

Use of Insulin (in%)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	9
Biguanides (BG)	7
Sulfonylurea (SU)	12
α-glucosidase (AGI)	10
Glinide	12
Thiazolidinedione (TZD)	8
Total	9

Percentage of Comorbidities by OAD Classes. Primary · On the index month

The additional diseases co-occuring, defined by International classification of Diseases, tenth revision (ICD-10) code. Results observed were based on index dates used for comparing drugs between the classes.

Hypertension (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	69
Biguanides (BG)	66
Sulfonylurea (SU)	66
α-glucosidase (AGI)	70
Glinide	73
Thiazolidinedione (TZD)	68
Total	68

Ischemic heart disease (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	30
Biguanides (BG)	27
Sulfonylurea (SU)	29
α-glucosidase (AGI)	33
Glinide	33
Thiazolidinedione (TZD)	28
Total	30

Myocardial infarction (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	14
Biguanides (BG)	13
Sulfonylurea (SU)	14
α-glucosidase (AGI)	15
Glinide	14
Thiazolidinedione (TZD)	12
Total	14

Heart failure (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	25
Biguanides (BG)	19
Sulfonylurea (SU)	23
α-glucosidase (AGI)	27
Glinide	28
Thiazolidinedione (TZD)	19
Total	24

Stroke (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	26
Biguanides (BG)	22
Sulfonylurea (SU)	26
α-glucosidase (AGI)	26
Glinide	27
Thiazolidinedione (TZD)	25
Total	25

Renal impairment (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	19
Biguanides (BG)	10
Sulfonylurea (SU)	14
α-glucosidase (AGI)	23
Glinide	26
Thiazolidinedione (TZD)	11
Total	18

Diabetic foot (in %)

Group	Value	95% CI
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	9
Biguanides (BG)	8
Sulfonylurea (SU)	9
α-glucosidase (AGI)	10
Glinide	14
Thiazolidinedione (TZD)	8
Total	9

Sponsor's own description

Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient data on dose adjustment in accordance with the prescription pattern and the risk of RI of OADs, in particular Dipeptidyl-peptidase-4 inhibitors, in clinical practice in Japan. Therefore, we will investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical practice in Japan

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Persistence of oral antidiabetic treatment for type 2 diabetes characterized by drug class, patient characteristics and severity of renal impairment: A Japanese database analysis.
Kadowaki T, Sarai N, Hirakawa T, Taki K, et al · · 2018 · cited 18× · PMID 29974673 · DOI 10.1111/dom.13463

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

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NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

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 NCT03092752 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 5 July 2019

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/NCT03092752.

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