Phase 4
Completed N=84
Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
Source: ClinicalTrials.gov NCT00367055 ↗Enrolled (actual)
84
Serious AEs
23.8%
Results posted
Nov 2009
Primary outcomePrimary: Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment — -3.9; -75.3; 7.0; 74.6 picomoles/L per minute (pmol/L*min) — p=0.376
Summary
It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment |
-3.9; -75.3; 7.0; 74.6; -8.6; 3.6 | 0.376 |
| SECONDARY Median Change From Baseline in the Ratio M/I After a 36-month Treatment |
— | — |
| SECONDARY Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment |
18.3; -32.3; 22.3; 60.7; 55.9; -7.6 | — |
| SECONDARY Mean Change From Baseline in HbA1c at Month 36 |
-0.22; 0.3 | — |
| SECONDARY Mean Change From Baseline in FBG at Month 36 |
-1.6; -0.2 | — |
| SECONDARY Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment |
— | — |
| SECONDARY Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment |
— | — |
| SECONDARY Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment |
— | — |
| SECONDARY Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment |
— | — |
| SECONDARY Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36 |
-0.00511; -0.02045; 0.00040; -0.01702 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Males and females 40 to 75 years of age (inclusive at the time of screening)
- Type 2 diabetes mellitus as defined by the WHO criteria, diagnosed for at least 1 year
- Subjects receiving 1.5 to 3g of metformin alone at a constant dose for at least 8 weeks prior to visit 1
- Patients with 6.5% 8% at visit 1 and visit 2
- 25 200 mg/dL at visit 2
- Hypersensitivity to the studied treatments (rosiglitazone, metformin chlorhydrate, gliclazide)
- Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
- Respiratory insufficiency
- Subjects who have required the use of insulin for glycaemic control in the past 6 months prior to visit 1 (except during pregnancy or acute episodes such as hospitalization, trauma or infection) or subjects with a history of metabolic acidosis including diabetic ketoacidosis
- Anemia defined by haemoglobin concentration 2.5 times the upper limit of the normal reference range
- Subjects with chronic diseases requiring periodic ot intermittent treatment with oral or IV corticosteroids
- Subjects receiving danazol, miconazole or phenylbutazone
- Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
- Women who are lactating, pregnant or planning to become pregnant
- Any clinically significant abnormality identified at screening which, in the investigator's judgement, makes the subject unsuitable for inclusion in the study
- Use of any other investigational agent within 30 days or 5 half-lives (whichever is longer) prior to visit 1
- Subjects who receive or anticipate receiving radiocontrast dye during the study
Data sourced from ClinicalTrials.gov (NCT00367055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.