Phase 3 · Exenatide

NCT00960661 trial results

A Randomized 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 Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 (percent of hemoglobin), Baseline, 30 weeks. Exenatide (BET): -1.13; Insulin Lispro (BBT): -1.10.

Participants
1,036
Status
completed
Completed
2012-08
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00960661), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00960661 measured first

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30percent of hemoglobin · Baseline, 30 weeks · least squares mean
Exenatide (BET)n=247Insulin Lispro (BBT)n=263
-1.13(0.053)-1.10(0.051)
Side effects by arm

Side effects in NCT00960661

Percent of participants affected. The most common events the registry lists.

EventExenatide (BET)Insulin Lispro (BBT)
Any serious event7.3%8.3%
Nausea32.4%1.6%
Vomiting12.4%1%
Nasopharyngitis11.7%6.4%
Diarrhoea10.8%5.1%
Dyspepsia6%1%
Bronchitis5.7%1.9%
Influenza5.7%5.1%
Headache5.7%3.5%
Back Pain3.8%1.6%
Decreased appetite3.8%0%
Abdominal pain3.5%0.3%
Urinary tract infection3.5%2.2%
Dizziness3.2%1.3%
Pharyngitis2.9%2.2%
arthralgia1.3%2.9%
Gastroenteritis2.5%0.6%
Constipation2.2%0.6%
musculoskeletal pain1%2.2%
tooth infection0.6%2.2%
Gastritis1.9%1%
Abdominal pain upper1.9%0.6%
pain in extremity1.6%1.9%
upper respiratory tract infection1%1.9%
hypertension0.6%1.9%
toothache0.3%1.9%
Secondary outcomes

What else it measured

Percentage of Participants Achieving HbA1C < 7.0%Percentage of participants · Week 30 · number
Exenatide (BET)n=244Insulin Lispro (BBT)n=263
46.742.6
Percent of Participants Achieving HbA1c ≤ 6.5%.percentage of participants · Week 30 · number
Exenatide (BET)n=244Insulin Lispro (BBT)n=263
26.225.5
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.mmol/L · Baseline, Week 30 · least squares mean
Exenatide (BET)n=243Insulin Lispro (BBT)n=262
-0.46(0.155)0.18(0.150)
Change in Total Cholesterol From Baseline to Week 30mmol/L · Baseline, week 30 · least squares mean
Exenatide (BET)n=237Insulin Lispro (BBT)n=254
-0.14(0.050)-0.03(0.049)
Change in High Density Lipoprotein (HDL) From Baseline to Week 30mmol/L · Baseline, week 30 · least squares mean
Exenatide (BET)n=237Insulin Lispro (BBT)n=254
-0.04(0.012)0.03(0.012)
Change in Low Density Lipoprotein (LDL) From Baseline to Week 30mmol/L · Baseline, Week 30 · least squares mean
Exenatide (BET)n=232Insulin Lispro (BBT)n=245
-0.12(0.042)-0.03(0.042)
Change in Body Weight From Baseline to Week 30.kg · baseline, week 30 · least squares mean
Exenatide (BET)n=247Insulin Lispro (BBT)n=263
-2.45(0.255)2.11(0.247)
Change in Systolic Blood Pressure (SBP) From Baseline to Week 30mmHg · Baseline, Week 30 · least squares mean
Exenatide (BET)n=207Insulin Lispro (BBT)n=227
-4.13(0.952)0.37(0.919)
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30mmHg · baseline, Week 30 · least squares mean
Exenatide (BET)n=207Insulin Lispro (BBT)n=227
-0.64(0.594)-0.14(0.572)
Daily Insulin Glargine Dose at Baseline and at Week 30IU/day · Baseline, week 30 · mean
MeasureExenatide (BET)n=247Insulin Lispro (BBT)n=263
Baseline61.5(30.94)61.1(35.24)
Week 3056.9(29.35)51.5(31.44)
Major Hypoglycemia Rate Per Yearrate per year · 30 weeks · mean
Exenatide (BET)n=315Insulin Lispro (BBT)n=312
0.0(0.23)0.1(0.39)
Minor Hypoglycemia Rate Per Yearrate per year · 30 weeks · mean
Exenatide (BET)n=315Insulin Lispro (BBT)n=312
2.1(5.08)5.0(12.83)
The trial

How NCT00960661 was run

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.

  • Exenatide (BET): Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
  • Insulin Lispro (BBT): Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
Who could join the trial

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.

Published papers

Papers from NCT00960661

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.