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CompletedNCT00318656Updated May 7, 2009Results posted

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

A Phase 4 interventional study of rosiglitazone-metformin fixed dose combination and metformin + glimepiride in Non-Insulin-Dependent Diabetes Mellitus, sponsored by GlaxoSmithKline. Completed. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-05-07.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Non-Insulin-Dependent Diabetes Mellitus

Keywords

  • type 2 diabetes
  • rosiglitazone
  • metformin
  • glimepiride
  • glycemia
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 23 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Interventions

  • Drugrosiglitazone-metformin fixed dose combination
  • Drugmetformin + glimepiride

    Drug pages: Metformin · Glimepiride

    Also known as: rosiglitazone-metformin fixed dose combination

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. 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.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. 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.

    Time frame: Baseline and 12 weeks

  3. 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.

    Time frame: Baseline and 12 weeks

  4. 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.

    Time frame: Baseline and 12 weeks

  5. 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.

    Time frame: Baseline and 12 weeks

  6. 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.

    Time frame: Baseline and 12 weeks

  7. HbA1c (Glycosylated Hemoglobin)

    Uncontrolled HbA1c\>8.5%. HbA1c and fasting blood glucose taken at hospital

    Time frame: Baseline and 12 weeks

  8. 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.

    Time frame: Baseline and 12 weeks

  9. 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.

    Time frame: Baseline and 12 weeks

  10. 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.

    Time frame: Baseline and 12 weeks

  11. 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.

    Time frame: Baseline and 12 weeks

  12. 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.

    Time frame: Baseline and 12 weeks

  13. 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.

    Time frame: Baseline and 12 weeks

  14. 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.

    Time frame: Baseline and 12 weeks

  15. 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.

    Time frame: Baseline and 12 weeks

07

Results

Posted Mar 18, 2009

Participant flow

Participant flow — Overall Study
MilestoneAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Started1211
Completed129
Not completed02
Withdrew: Took avandamet instead of glim/met01
Withdrew: Did not receive any treatment01

Outcome measures

PrimaryDuration 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Hours
Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
HoursAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline17.31 ± 6.2517.53 ± 6.84
12 weeks15.30 ± 6.1010.83 ± 6.06
Statistical analysis
  • Avandamet® (Rosiglitazone/Metformin) vs Glimepiride/Metformin · ANCOVA · p = 0.064 · Mean difference (net): 5.02 · 95% CI -0.32 to 10.36Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)
PrimaryEpisodes 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Episodes
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
EpisodesAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline3.91 ± 2.034.05 ± 2.51
12 weeks5.36 ± 2.675.90 ± 3.01
Statistical analysis
  • Avandamet® (Rosiglitazone/Metformin) vs Glimepiride/Metformin · ANCOVA · p = 0.923 (P value von elteren (adjusted on sex)) · Mean difference (net): -0.26 · 95% CI -3.37 to 2.85Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)
SecondaryDuration 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Hours
Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
HoursAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline11.28 ± 8.6712.35 ± 7.13
12 weeks6.39 ± 5.304.23 ± 5.32
SecondaryEpisodes 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Episodes
Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
EpisodesAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline4.00 ± 1.953.55 ± 1.34
12 weeks5.00 ± 2.982.95 ± 2.83
SecondaryDuration 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Hours
Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
HoursAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline0.85 ± 1.540.24 ± 0.45
12 weeks0.64 ± 1.970.41 ± 0.80
SecondaryEpisodes 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Episodes
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
EpisodesAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline0.64 ± 0.870.30 ± 0.63
12 weeks0.50 ± 1.360.80 ± 1.60
SecondaryDuration 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Hours
Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
HoursAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline0.51 ± 1.060 ± 0
12 weeks0.14 ± 0.470.08 ± 0.26
SecondaryEpisodes 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Episodes
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
EpisodesAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline0.50 ± 1.020 ± 0
12 weeks0.14 ± 0.450.1 ± 0.32
SecondaryHbA1c (Glycosylated Hemoglobin)

Uncontrolled HbA1c\>8.5%. HbA1c and fasting blood glucose taken at hospital

Time frame:
Baseline and 12 weeks
Reported as:
Mean · Percentage
HbA1c (Glycosylated Hemoglobin)
PercentageAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline7.8 ± 0.657.7 ± 0.50
12 weeks7.4 ± 0.627.1 ± 0.79
Secondary8-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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · pg/mL
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate
pg/mLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline361.9 ± 207.53325.1 ± 148.2
12 weeks373.5 ± 180.15320.4 ± 84.74
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (Nocturnal), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline148.4 ± 42.94140.4 ± 30.18
12 weeks130.2 ± 21.97126.3 ± 21.76
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (Diurnal), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline162.1 ± 43.1158.7 ± 27.40
12 weeks139.1 ± 15.23130.13 ± 21.17
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (Dawn), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline145.0 ± 37.23138.6 ± 23.44
12 weeks130.6 ± 21.31124.7 ± 20.26
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline1428.2 ± 971.31293.1 ± 636.3
12 weeks891.4 ± 342.4717.7 ± 460.6
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline522.8 ± 271.6443.0 ± 157.9
12 weeks356.9 ± 138.4362.7 ± 177.3
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline905.6 ± 728.2850.1 ± 601.2
12 weeks534.5 ± 307.5355.0 ± 338.2
SecondaryGlycaemia 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mg/dL
Glycaemia According to CGMS (MAGE), mg/dL
mg/dLAvandamet® (Rosiglitazone/Metformin)Glimepiride/Metformin
Baseline75.1 ± 22.561.6 ± 13.7
12 weeks44.2 ± 18.350.8 ± 16.4

Baseline characteristics

Age Continuous
Age Continuous(years)Avandamet® (Rosiglitazone/Metformin)Glimepiride/MetforminTotal
Mean59 ± 10.362.2 ± 6.660.5 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Avandamet® (Rosiglitazone/Metformin)Glimepiride/MetforminTotal
Female527
Male6814
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m²)Avandamet® (Rosiglitazone/Metformin)Glimepiride/MetforminTotal
Mean32.2 ± 6.630.1 ± 4.831.2 ± 5.8
HbA1c
HbA1c(percentage)Avandamet® (Rosiglitazone/Metformin)Glimepiride/MetforminTotal
Mean7.8 ± 0.517.8 ± 0.527.8 ± 0.50
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00318656
Lead sponsor
GlaxoSmithKline
First posted
Apr 27, 2006
Start date
Nov 2005
Primary completion
Oct 2007
Completion
Oct 2007
Results posted
Mar 18, 2009
Last update
May 7, 2009

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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