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Type 2 Diabetes MellitusPhase 4NCT00367055

Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

A Phase 4 study testing rosiglitazone-metformin, Metformin and metformin+ gliclazide in people with Type 2 Diabetes Mellitus, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
rosiglitazone-metformin, Metformin and metformin+ gliclazide
How many people
84 participants
Where
No sites listed yet
Study dates
Oct 2004to Oct 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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% < HbA1c > 8% at visit 1 and visit 2
  • 25 < BMI < 35

Who cannot join

  • Patient with type 1 diabetes
  • Treatment with other hypoglycaemic agents than metformin in the last 3 months
  • FPG >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
Show all 17Show fewer
  • 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 <11.0 g/dL for males and <10.0 g/dL for females
  • Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135.0 µmol/L in males and ≥110.0 µmol/L in females and/or creatinine clearance <40 mL/min
  • Presence of clinically significant hepatic disease, with ALT, AST, total bilirubin, alkaline phosphatase >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

About this study

Official title: Comparison of the Action of the Rosiglitazone-metformin Fixed-dose Combination and of a Metformin-sulfonylurea Free Combination on the B-cell Function in Type 2 Diabetic Patients Not Controlled With Metformin Alone.

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.

Being tested
rosiglitazone-metformin, Metformin, metformin+ gliclazide
Keywords
Beta cell function, Type 2 diabetes, Combination treatment
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rosiglitazone-metforminDrug

  • MetforminDrug

  • metformin+ gliclazideDrug

    Also called rosiglitazone-metformin, Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment

    Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).

    Measured: Baseline and Month 36

Secondary outcomes (9)

  1. Median Change From Baseline in the Ratio M/I After a 36-month Treatment

    Measured: Baseline and Month 36

  2. Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment

    Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion.

    Measured: Baseline and Month 18

  3. Mean Change From Baseline in HbA1c at Month 36

    Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw.

    Measured: Baseline and Month 36

  4. Mean Change From Baseline in FBG at Month 36

    Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw.

    Measured: Baseline and Month 36

  5. Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment

    Measured: Baseline and Month 36

  6. Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment

    Measured: Baseline and Month 36

  7. Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment

    Measured: Baseline and Month 36

  8. Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment

    Measured: Baseline and Month 36

  9. Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36

    Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration.

    Measured: Baseline and Months 18 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2006 (estimated)
  2. Study startOct 2004
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00367055
Sponsor's protocol ID
101765
Other IDs
AVAF4001
Status last verified
Jul 2010
First submitted
21 Aug 2006
Last updated
27 Jul 2010

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosiglitazone-metformin, Metformin and metformin+ gliclazide in people with Type 2 Diabetes Mellitus, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment (time frame: Baseline and Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00367055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.

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