Phase 3
N=1,036
A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00960661 ↗Enrolled (actual)
1,036
Serious AEs
7.8%
Results posted
Dec 2013
Primary outcome: Primary: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 — -1.13; -1.10 percent of hemoglobin — p=0.6273
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exenatide (Drug); insulin lispro (Drug); Metformin (Drug); Insulin/ Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 |
-1.13; -1.10 | 0.6273 |
| SECONDARY Percentage of Participants Achieving HbA1C < 7.0% |
46.7; 42.6 | — |
| SECONDARY Percent of Participants Achieving HbA1c ≤ 6.5%. |
26.2; 25.5 | — |
| SECONDARY Change in Fasting Blood Glucose (FBG) From Baseline to Week 30. |
-0.46; 0.18 | — |
| SECONDARY Change in Total Cholesterol From Baseline to Week 30 |
-0.14; -0.03 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) From Baseline to Week 30 |
-0.04; 0.03 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) From Baseline to Week 30 |
-0.12; -0.03 | — |
| SECONDARY Change in Body Weight From Baseline to Week 30. |
-2.45; 2.11 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 30 |
-4.13; 0.37 | — |
| SECONDARY Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30 |
-0.64; -0.14 | — |
| SECONDARY Daily Insulin Glargine Dose at Baseline and at Week 30 |
61.5; 61.1; 56.9; 51.5 | — |
| SECONDARY Major Hypoglycemia Rate Per Year |
0.0; 0.1 | — |
| SECONDARY Minor Hypoglycemia Rate Per Year |
2.1; 5.0 | — |
Summary
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
Eligibility Criteria
Inclusion Criteria
- Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
- Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
- Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
- Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
- Have an HbA1C > 7.0% and ≤ 10.0%.
- Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
Exclusion Criteria
- Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
- Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
- Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have previously completed or been withdrawn from this study after enrollment.
Data sourced from ClinicalTrials.gov (NCT00960661). 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.