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Completed

NCT Number: NCT00135330

An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HbA1c of 6.8% to 10.0%, inclusive.
  • Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

Exclusion criteria

  • Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors
  • Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.
  • Treated with any of the following medications:
  • Thiazolidinedione within 5 months of screening;
  • Sulfonylurea within 3 months of screening;
  • Metformin/sulfonylurea combination therapy within 3 months of screening;
  • Alpha-glucosidase inhibitor within 3 months of screening;
  • Meglitinide within 3 months of screening;
  • Insulin for more than 1 week within the 3 months prior to screening.
  • Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
  • Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
  • Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
  • Systemic antineoplastic agent
  • Systemic transplantation medication
  • Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg or 10mcg, twice a day

Other names: Byetta

rosiglitazone

Drug

oral tablet, 2mg or 4mg, twice a day

Other names: Avandia

Primary outcomes

  1. Change in ASIiAUC During a Hyperglycemic Clamp Test.

    Time frame: 20 weeks

    Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.

Secondary outcomes

  1. Change in AUC for Glucose During a Meal Challenge Test (MCT).

    Time frame: Week 20

    Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.

  2. Change in Insulin Sensitivity Index as Measured by M-value.

    Time frame: Week 20

    Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.

  3. Change in Insulin AUC in the First Stage From Baseline to Endpoint.

    Time frame: Week 20

    Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.

  4. Change in Insulin iAUC From Baseline to Endpoint.

    Time frame: Week 20

    Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.

  5. Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).

    Time frame: Week 20

    Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.

  6. Change in AUC for C-peptide During a Meal Challenge Test (MCT).

    Time frame: Week 20

    Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.

  7. Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).

    Time frame: Week 20

    Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.

  8. Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).

    Time frame: Week 20

    Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.

  9. Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).

    Time frame: Week 20

    Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.

  10. Change in HbA1c

    Time frame: Week 20

    Change in HbA1c from baseline to week 20.

  11. Change in Fasting Serum Glucose Concentration.

    Time frame: Week 20

    Change in fasting serum glucose concentration from baseline to week 20.

  12. Change in Fasting C-peptide

    Time frame: Week 20

    Change in fasting C-peptide from baseline to week 20.

  13. Change in Fasting Insulin

    Time frame: Week 20

    Change in fasting insulin from baseline to week 20.

  14. Change in Fasting Proinsulin

    Time frame: Week 20

    Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline

  15. Change in Body Weight

    Time frame: Week 20

    Change in body weight from baseline to week 20.

  16. Change in Fasting Total Cholesterol.

    Time frame: Week 20

    Change in fasting total cholestrol from baseline to week 20.

  17. Change in Fasting HDL Cholesterol

    Time frame: Week 20

    Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.

  18. Change in Fasting LDL Cholesterol

    Time frame: Week 20

    Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.

  19. Change in Fasting Triglycerides

    Time frame: Week 20

    Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.

  20. Change in Percent Body Fat During a Meal Challenge Test (MCT)

    Time frame: 20 weeks

    Change in percent body fat from baseline to week 20, as assessed during an MCT

  21. Change in Body Fat Mass During a Meal Challenge Test (MCT)

    Time frame: 20 weeks

    Change in body fat mass form baseline to week 20, as assessed during an MCT

  22. Change in Lean Body Mass During a Meal Challenge Test (MCT)

    Time frame: 20 weeks

    Change in lean body mass from baseline to week 20, as assessed during an MCT

  23. Change in Waist Circumference

    Time frame: 20 weeks

    Change in waist circumference from baseline to week 20

  24. Change in Hip Circumference

    Time frame: 20 weeks

    Change in hip circumference form baseline to week 20

  25. Change in Waist-to-hip Ratio

    Time frame: 20 weeks

    Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20

  26. Incidence of Hypoglycemia Events

    Time frame: 20 weeks

    Number of subjects experiencing hypoglycemia at any point during the study

  27. Hypoglycemia Rate Per 30 Days Per Patient

    Time frame: 20 weeks

    Average number of episodes of hypoglycemia per 30 days per patient

  28. Pedal Edema Score

    Time frame: 20 weeks

    Pedal edema scores experienced by each patient throughout the study ("1+" indicates a patient experienced a pedal edema score of 1 , 2, or 3; "2+" indicates a patient experienced a pedal edema score of 2 or 3, etc.)

    Scale:

    • Slight pitting, no visible distortion, disappears rapidly
    • A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds
    • The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen
    • The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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