Primary outcomeLeast squares mean· Baseline, 30 weeks
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
| Group | Value (percent of hemoglobin) | Spread |
|---|---|---|
| Exenatide (BET) | -1.13 | 0.053 |
| Insulin Lispro (BBT) | -1.10 | 0.051 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA 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
NCTNCT00960661 (opens ClinicalTrials.gov in a new tab)Other idH8O-EW-GWDM
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 1,036 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Open label (no masking)
- Countries
18 countries
Argentina, Belgium, Estonia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, United Kingdom
- Start
- Sept 2009
- Primary completion
- Aug 2012
- Completion
- Aug 2012
- First posted
- 18 Aug 2009 (estimated)
- Last update posted
- 7 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20092010201120122013
- Ph 3
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
NCT00960661Sept 2009 to Aug 2012
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatideDrug
- insulin lisproDrug
- MetforminDrug
- Insulin/ GlargineDrug
Arms2
Experimental
Exenatide (BET)
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
Active comparator
Insulin Lispro (BBT)
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
Time frame · Baseline, 30 weeks
Registry description
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).
Secondary outcomes(12)
Percentage of Participants Achieving HbA1C < 7.0%
Time frame · Week 30
Registry description
Percentage of participants achieving HbA1C \< 7.0%
Percent of Participants Achieving HbA1c ≤ 6.5%.
Time frame · Week 30
Registry description
Percent of participants achieving HbA1c ≤ 6.5%.
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
Time frame · Baseline, Week 30
Registry description
Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Change in Total Cholesterol From Baseline to Week 30
Time frame · Baseline, week 30
Registry description
Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Change in High Density Lipoprotein (HDL) From Baseline to Week 30
Time frame · Baseline, week 30
Registry description
Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Change in Low Density Lipoprotein (LDL) From Baseline to Week 30
Time frame · Baseline, Week 30
Registry description
Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Change in Body Weight From Baseline to Week 30.
Time frame · baseline, week 30
Registry description
Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Change in Systolic Blood Pressure (SBP) From Baseline to Week 30
Time frame · Baseline, Week 30
Registry description
Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30
Time frame · baseline, Week 30
Registry description
Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Daily Insulin Glargine Dose at Baseline and at Week 30
Time frame · Baseline, week 30
Registry description
Daily Insulin Glargine Dose at baseline and at Week 30
Major Hypoglycemia Rate Per Year
Time frame · 30 weeks
Registry description
Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.
Minor Hypoglycemia Rate Per Year
Time frame · 30 weeks
Registry description
Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 30
Percentage of Participants Achieving HbA1C < 7.0%
| Group | Value (Percentage of participants) |
|---|---|
| Exenatide (BET) | 46.7 |
| Insulin Lispro (BBT) | 42.6 |
Secondary outcomeNumber· Week 30
Percent of Participants Achieving HbA1c ≤ 6.5%.
| Group | Value (percentage of participants) |
|---|---|
| Exenatide (BET) | 26.2 |
| Insulin Lispro (BBT) | 25.5 |
Secondary outcomeLeast squares mean· Baseline, Week 30
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide (BET) | -0.46 | 0.155 |
| Insulin Lispro (BBT) | 0.18 | 0.150 |
Secondary outcomeLeast squares mean· Baseline, week 30
Change in Total Cholesterol From Baseline to Week 30
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide (BET) | -0.14 | 0.050 |
| Insulin Lispro (BBT) | -0.03 | 0.049 |
Secondary outcomeLeast squares mean· Baseline, week 30
Change in High Density Lipoprotein (HDL) From Baseline to Week 30
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide (BET) | -0.04 | 0.012 |
| Insulin Lispro (BBT) | 0.03 | 0.012 |
Secondary outcomeLeast squares mean· Baseline, Week 30
Change in Low Density Lipoprotein (LDL) From Baseline to Week 30
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide (BET) | -0.12 | 0.042 |
| Insulin Lispro (BBT) | -0.03 | 0.042 |
Secondary outcomeLeast squares mean· baseline, week 30
Change in Body Weight From Baseline to Week 30.
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide (BET) | -2.45 | 0.255 |
| Insulin Lispro (BBT) | 2.11 | 0.247 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide (BET)Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) | – | 23 / 315 | 228 / 315 |
| Insulin Lispro (BBT)Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) | – | 26 / 312 | 175 / 312 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultDiamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10. PMID 25011946
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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