20 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo GroupPrimary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were una
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
-0.62
± 0.074
Placebo
0.19
± 0.073
Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)Secondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
-15.9
± 28.91
Placebo
6.2
± 32.69
Change From Baseline After 16 Weeks of Treatment in Fasting InsulinSecondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
-0.479
± 3.2699
Placebo
-1.197
± 6.1434
Change From Baseline After 16 Weeks of Treatment in Fasting ProinsulinSecondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
-1.64
± 13.630
Placebo
0.40
± 11.666
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)Secondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
-0.496
± 1.5562
Placebo
-0.486
± 3.7556
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)Secondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
3.776
± 18.7875
Placebo
-4.444
± 24.0408
Change From Baseline After 16 Weeks of Treatment in AdiponectinSecondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
9.19
± 7.030
Placebo
0.98
± 2.301
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)Secondary· Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Leptin
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
0.59
± 2.751
Placebo
-0.07
± 1.332
Hs-CRP
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
-189.1
± 5376.91
Placebo
699.7
± 4349.58
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of TreatmentSecondary· Up to Week 16
The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.
HbA1c, decrease by 0.7%
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
44.6
Placebo
4.0
HbA1c, fell below 6.5%
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
6.8
Placebo
0.0
HbA1c, satisfied either 1 or 2
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
44.6
Placebo
4.0
FPG, decrease of 30 milligrams per decilliter
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
31.1
Placebo
8.0
FPG, fell below 126 milligrams per deciliter
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
16.2
Placebo
9.3
FPG, satisfied either 1 or 2
Group
Value
95% CI
Rosiglitazone 4 mg Orally Once Daily
35.1
Placebo
14.7
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rosiglitazone 4 mg Orally Once Daily
Serious: 1/74 (1%)
Deaths: 0/74
Placebo
Serious: 1/75 (1%)
Deaths: 0/75
Serious adverse events (2 terms)
Reaction
System
Rosiglitazone 4 mg Orally …
Placebo
Liposacromal recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Brain stem infarction
Nervous system disorders
—
—
Other adverse events (122 terms — click to expand)
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Trials by the same sponsor.
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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: 12 December 2022
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/NCT00432679.