Phase 3
N=137
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00135330 ↗Enrolled (actual)
137
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Change in ASIiAUC During a Hyperglycemic Clamp Test. — 643.40; 686.41; 786.12; 747.26 uIU-min/ml — p=0.282
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exenatide (Drug); rosiglitazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ASIiAUC During a Hyperglycemic Clamp Test. |
643.40; 686.41; 786.12; 747.26; 194.68; -99.85 | 0.282 |
| SECONDARY Change in AUC for Glucose During a Meal Challenge Test (MCT). |
1782.86; 1799.68; 1741.87; -560.12; -635.24; -425.59 | 0.004 sig |
| SECONDARY Change in Insulin Sensitivity Index as Measured by M-value. |
3.89; 2.49; 4.02; 0.477; 2.07; 1.42 | 0.308 |
| SECONDARY Change in Insulin AUC in the First Stage From Baseline to Endpoint. |
200.50; 136.84; 157.49; 134.88; 32.12; -50.81 | 0.079 |
| SECONDARY Change in Insulin iAUC From Baseline to Endpoint. |
5.98; -9.92; 23.09; 99.08; 53.71; 11.51 | 0.252 |
| SECONDARY Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT). |
5171.40; 4324.13; 5816.83; 0.806; 0.664; 0.722 | 0.465 |
| SECONDARY Change in AUC for C-peptide During a Meal Challenge Test (MCT). |
319.77; 310.51; 325.65; 0.908; 0.804; 0.854 | 0.348 |
| SECONDARY Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT). |
0.950; 1.12; 0.828; -0.651; -0.286; 0.150 | — |
| SECONDARY Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT). |
9.97; 8.09; 7.53; -1.71; -1.84; -0.455 | — |
| SECONDARY Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT). |
0.238; 0.259; 0.206; -0.006; 0.016; 0.087 | — |
| SECONDARY Change in HbA1c |
7.79; 7.84; 7.92; -0.908; -1.31; -0.968 | 0.039 sig |
| SECONDARY Change in Fasting Serum Glucose Concentration. |
8.42; 8.43; 8.48; -1.46; -1.60; -1.80 | 0.555 |
| SECONDARY Change in Fasting C-peptide |
— | — |
| SECONDARY Change in Fasting Insulin |
12.84; 10.96; 12.77; 0.980; 0.599; 0.755 | 0.106 |
| SECONDARY Change in Fasting Proinsulin |
4.32; 3.80; 3.56; 0.663; 0.538; 0.623 | 0.341 |
| SECONDARY Change in Body Weight |
93.05; 93.76; 91.78; -2.82; -1.21; 1.48 | <0.001 sig |
| SECONDARY Change in Fasting Total Cholesterol. |
4.42; 4.41; 4.62; -0.128; 0.258; 0.438 | 0.276 |
| SECONDARY Change in Fasting HDL Cholesterol |
1.13; 1.17; 1.17; 0.022; 0.046; 0.055 | 0.840 |
| SECONDARY Change in Fasting LDL Cholesterol |
2.59; 2.57; 2.71; -0.049; 0.096; 0.334 | 0.096 |
| SECONDARY Change in Fasting Triglycerides |
1.56; 1.67; 1.76; 0.861; 0.977; 0.992 | 0.875 |
| SECONDARY Change in Percent Body Fat During a Meal Challenge Test (MCT) |
33.42; 34.07; 32.50; -1.40; -0.347; -1.18 | 0.581 |
| SECONDARY Change in Body Fat Mass During a Meal Challenge Test (MCT) |
32.05; 32.55; 30.54; -2.76; -1.06; -1.99 | 0.631 |
| SECONDARY Change in Lean Body Mass During a Meal Challenge Test (MCT) |
64.62; 60.94; 61.09; -2.99; 0.532; 1.23 | 0.724 |
| SECONDARY Change in Waist Circumference |
105.98; 106.85; 105.34; -2.95; -2.38; -0.225 | 0.117 |
| SECONDARY Change in Hip Circumference |
113.29; 112.12; 111.90; -1.28; 0.147; 1.51 | 0.251 |
| SECONDARY Change in Waist-to-hip Ratio |
0.939; 0.957; 0.943; -0.016; -0.022; -0.016 | 0.710 |
| SECONDARY Incidence of Hypoglycemia Events |
8; 9; 6 | 0.575 |
| SECONDARY Hypoglycemia Rate Per 30 Days Per Patient |
0.391; 0.594; 0.853 | 0.436 |
| SECONDARY Pedal Edema Score |
37; 34; 30; 7; 11; 14 | 0.168 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00135330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.