Non-Insulin-Dependent Diabetes MellitusPhase 4NCT00318656

24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

A Phase 4 study testing rosiglitazone-metformin fixed dose combination and metformin + glimepiride in people with Non-Insulin-Dependent 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

Search all trials

Trial summary

A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride). Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Non-Insulin-Dependent Diabetes Mellitus
What is being tested?: rosiglitazone-metformin fixed dose combination and metformin + glimepiride
How many people: 23 participants
Where: No sites listed yet
Study dates: Nov 2005to Oct 2007
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females aged 40 to 80 years
Diagnosis of type 2 diabetes mellitus for at least 6 months
Body mass index (BMI) ≥25kg/m2
7%≥HbA1c ≤ 9% at visit 2
Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1
Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures
Written informed consent

Who cannot join

Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening
Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure
Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis
Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1
Subjects with a history of severe hypoglycaemia
Anemia defined by haemoglobin concentration <11.0g/dL for males or <10.0g/dL for females

Show all 15Show fewer

Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females
Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase >2.5 times the upper limit of the normal reference range)
Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
Female who are lactating, pregnant, or planning to become pregnant
Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...)
Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study
Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
Subjects not willing to comply with the procedures described in this protocol.

About this study

Official title: Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.

Conditions: Non-Insulin-Dependent Diabetes Mellitus
Being tested: rosiglitazone-metformin fixed dose combination, metformin + glimepiride
Keywords: type 2 diabetes, rosiglitazone, metformin, glimepiride, glycemia
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-metformin fixed dose combinationDrug
metformin + glimepirideDrug
Also called rosiglitazone-metformin fixed dose combination

What is being measured

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

Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks

Secondary outcomes (15)

Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Measured: Baseline and 12 weeks
HbA1c (Glycosylated Hemoglobin)
Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital
Measured: Baseline and 12 weeks
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate
8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (Nocturnal), mg/dL
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (Diurnal), mg/dL
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (Dawn), mg/dL
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia "at dawn" measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
Measured: Baseline and 12 weeks
Glycaemia According to CGMS (MAGE), mg/dL
Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.
Measured: Baseline and 12 weeks

Timeline

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

Nov 2005Oct 2007

First posted27 Apr 2006 (estimated)
Study startNov 2005
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Insulin-Dependent Diabetes MellitusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00318656
Sponsor's protocol ID: 104988
Other IDs: AVAF4003
Status last verified: Apr 2009
First submitted: 25 Apr 2006
Last updated: 7 May 2009
Results posted: Yes, on ClinicalTrials.gov

Publications

Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.
PubMed 22775317

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Non-Insulin-Dependent Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.
ClinicalTrials.gov ID: NCT00318656
Acronym / sponsor ID: 104988
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Keywords: type 2 diabetes, rosiglitazone, metformin, glimepiride, glycemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 27 Apr 2006 (estimated)
Results: Posted 18 Mar 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Males and females aged 40 to 80 years
Diagnosis of type 2 diabetes mellitus for at least 6 months
Body mass index (BMI) ≥25kg/m2
7%≥HbA1c ≤ 9% at visit 2
Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1

Key exclusion criteria (15 listed)

Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening
Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure
Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis
Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1
Subjects with a history of severe hypoglycaemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rosiglitazone-metformin fixed dose combination	Drug	–
metformin + glimepirideAlso: rosiglitazone-metformin fixed dose combination	Drug	–

Primary outcome

Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

15 secondary outcomes

Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Time frame: Baseline and 12 weeks
HbA1c (Glycosylated Hemoglobin)
Time frame: Baseline and 12 weeks
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (Nocturnal), mg/dL
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (Diurnal), mg/dL
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (Dawn), mg/dL
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL
Time frame: Baseline and 12 weeks
Glycaemia According to CGMS (MAGE), mg/dL
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 18 Mar 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Avandamet® (Rosiglitazone/Metformin)	12	12
Glimepiride/Metformin	11	9

Primary outcome: Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment

Time frame: Baseline and 12 weeks. Mean (Standard Error). Unit: Hours

Measure	Avandamet® (Rosiglitazone/Metformin) n = 11	Glimepiride/Metformin n = 10
Baseline	17.31 (6.25)	17.53 (6.84)
12 weeks	15.30 (6.10)	10.83 (6.06)

Avandamet® (Rosiglitazone/Metformin) vs Glimepiride/Metformin: Mean Difference (Net): 5.02 (95% CI -0.32 to 10.36), p = 0.064, ANCOVA

Population analysed: ITT (randomized): This Intent-to-treat (ITT) population included all subjects who had been randomised, who had received at least one dose of study medication, and for whom at least one efficacy criteria on treatment period was available. The ITT population was the primary population for the efficacy analysis.

Primary outcome: Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment

Time frame: Baseline and 12 weeks. Mean (Standard Error). Unit: Episodes

Measure	Avandamet® (Rosiglitazone/Metformin) n = 11	Glimepiride/Metformin n = 10
Baseline	3.91 (2.03)	4.05 (2.51)
12 weeks	5.36 (2.67)	5.90 (3.01)

Avandamet® (Rosiglitazone/Metformin) vs Glimepiride/Metformin: Mean Difference (Net): -0.26 (95% CI -3.37 to 2.85), p = 0.923, ANCOVA

Population analysed: ITT (randomized)

15 secondary outcomes are reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22775317Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.

Related trials for Non-Insulin-Dependent Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials, MD study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosiglitazone-metformin fixed dose combination and metformin + glimepiride in people with Non-Insulin-Dependent 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 7 inclusion and 15 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 7 May 2009. 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 18 Mar 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?

Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00318656, which also lists 1 linked publication.

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 7 May 2009.