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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00135330 (opens ClinicalTrials.gov in a new tab)Other idH8O-US-GWAY
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
137 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2005
Primary completion
Jul 2008
Completion
Jul 2008
First posted
26 Aug 2005 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006200720082009
  1. Ph 3

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

    NCT00135330

    Oct 2005 to Jul 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatideDrug
  • rosiglitazoneDrug

Arms3

  • Experimental

    Exenatide Arm

  • Experimental

    Exenatide plus Rosiglitazone Arm

  • Experimental

    Rosiglitazone Arm

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in ASIiAUC During a Hyperglycemic Clamp Test.

    Time frame · 20 weeks

    Registry description

    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(20)

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

    Time frame · Week 20

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

  10. Change in HbA1c

    Time frame · Week 20

    Registry description

    Change in HbA1c from baseline to week 20.

  11. Change in Fasting Serum Glucose Concentration.

    Time frame · Week 20

    Registry description

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

  12. Change in Fasting C-peptide

    Time frame · Week 20

    Registry description

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

  13. Change in Fasting Insulin

    Time frame · Week 20

    Registry description

    Change in fasting insulin from baseline to week 20.

  14. Change in Fasting Proinsulin

    Time frame · Week 20

    Registry description

    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

    Registry description

    Change in body weight from baseline to week 20.

  16. Change in Fasting Total Cholesterol.

    Time frame · Week 20

    Registry description

    Change in fasting total cholestrol from baseline to week 20.

  17. Change in Fasting HDL Cholesterol

    Time frame · Week 20

    Registry description

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

  18. Change in Fasting LDL Cholesterol

    Time frame · Week 20

    Registry description

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

  19. Change in Fasting Triglycerides

    Time frame · Week 20

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 20 weeks

Change in ASIiAUC During a Hyperglycemic Clamp Test.

GroupValue (uIU-min/ml)Spread
Exenatide643.40106.71
Exenatide Plus Rosiglitazone686.41103.70
Rosiglitazone786.12113.60
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Week 20

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

GroupValue (mmol-min/L)Spread
Exenatide1782.8660.47
Exenatide Plus Rosiglitazone1799.6859.60
Rosiglitazone1741.8760.47
Secondary outcomeLeast squares mean· Week 20

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

GroupValue (mg/kg-min)Spread
Exenatide3.890.495
Exenatide Plus Rosiglitazone2.490.495
Rosiglitazone4.020.511
Secondary outcomeLeast squares mean· Week 20

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

GroupValue (uIU-min/ml)Spread
Exenatide200.5050.40
Exenatide Plus Rosiglitazone136.8450.40
Rosiglitazone157.4953.66
Secondary outcomeLeast squares mean· Week 20

Change in Insulin iAUC From Baseline to Endpoint.

GroupValue (uIU-min/ml)Spread
Exenatide5.9814.29
Exenatide Plus Rosiglitazone-9.9214.29
Rosiglitazone23.0915.21
Secondary outcomeGeometric mean· Week 20

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

GroupValue (uIU-min/ml)Spread
Exenatide5171.40522.82
Exenatide Plus Rosiglitazone4324.13430.87
Rosiglitazone5816.83596.91
Secondary outcomeGeometric mean· Week 20

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

GroupValue (nmol-min/L)Spread
Exenatide319.7718.13
Exenatide Plus Rosiglitazone310.5117.61
Rosiglitazone325.6519.04
Secondary outcomeLeast squares mean· Week 20

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

GroupValue (mmol/L)Spread
Exenatide0.9500.138
Exenatide Plus Rosiglitazone1.120.138
Rosiglitazone0.8280.142

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatideExenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.–3 / ?35 / ?
Exenatide Plus RosiglitazoneExenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.–4 / ?41 / ?
RosiglitazoneRosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.–4 / ?33 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman et al. 2012Diabetes, obesity & metabolismcited by 117

PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356

Full text at the publisher15 results
Publisher pageSee results (15)

Indexing hint: Randomized controlled trial · 2010

11 results

Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin.

DeFronzo et al. 2010Diabetes carecited by 85

PMID 20107105PMC2858197DOI 10.2337/dc09-1521PUB-20107105

Free to read · publisher termsCC BY-NC-ND11 results
Read at sourceSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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