Phase 3 · Exenatide

NCT00434954 trial results

Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

Change in Glycosylated Hemoglobin (HbA1c) (Percentage of glycosylated hemoglobin), Baseline and 26 weeks. Exenatide Twice Daily: -1.00; Premixed Insulin Aspart Twice Daily: -1.14.

Participants
494
Status
completed
Completed
2009-06
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00434954), 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 NCT00434954 measured first

Change in Glycosylated Hemoglobin (HbA1c)Percentage of glycosylated hemoglobin · Baseline and 26 weeks · least squares mean
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
-1.00(0.05)-1.14(0.05)
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)Percentage of participants · 26 weeks · number
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
8.020.5
Side effects by arm

Side effects in NCT00434954

Percent of participants affected, 26 weeks. The most common events the registry lists.

EventExenatide Twice DailyPremixed Insulin Aspart Twice Daily
Any serious event3.6%3.4%
Nausea18.6%3.4%
Nasopharyngitis15%18%
Diarrhea10.9%6.9%
Headache10.5%10.7%
Vomiting8.9%0.9%
Dyspepsia6.1%0.9%
Secondary outcomes

What else it measured

Percentage of Subjects Achieving HbA1c Target of < 6.5%Percentage of participants · 26 weeks · number
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
27.624.9
Percentage of Subjects Achieving HbA1c Target of < 7.0%Percentage of participants · 26 weeks · number
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
49.256.6
Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)Percentage of participants · 26 weeks · number
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
1.86.3
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)Percentage of participants · 26 weeks · number
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
3.97.0
7 Point Self-monitored Blood Glucose (SMBG) Profilesmg/dL · Baseline and 26 weeks · mean
MeasureExenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
Pre-breakfast at baseline (week 0)8.933(1.7138)9.005(2.0432)
Pre-breakfast at endpoint (week 26)7.774(1.7730)7.293(1.3349)
2 hrs post-breakfast at baseline (week 0)10.821(2.5306)10.902(2.8499)
2 hrs post-breakfast at endpoint (week 26)8.014(2.0557)8.304(2.1212)
Pre-lunch at baseline (week 0)8.443(2.1814)8.357(2.3221)
Pre-lunch at endpoint (week 26)7.506(1.8800)6.656(1.7011)
2 hrs post-lunch at baseline (week 0)9.698(2.2370)9.899(2.6433)
2 hrs post-lunch at endpoint (week 26)8.513(5.8997)8.216(1.6108)
Pre-dinner at baseline (week 0)8.684(2.0059)8.759(2.2174)
Pre-dinner at endpoint (week 26)7.616(2.1727)7.194(1.5572)
2 hrs post-dinner at baseline (week 0)10.241(2.2880)10.259(2.4868)
2 hrs post-dinner at endpoint (week 26)7.727(1.8820)8.143(1.5614)
Blood Lipid Levelsmmol/L · Baseline and 26 weeks · mean
MeasureExenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
Total cholesterol at baseline (week 0)5.147(1.0008)5.084(1.0079)
Total cholesterol at endpoint (week 26)4.971(0.9653)5.050(0.8933)
HDL cholesterol at baseline (week 0)1.234(0.3065)1.255(0.3324)
HDL cholesterol at endpoint (week 26)1.244(0.2805)1.319(0.3394)
LDL cholesterol (calculated) at baseline (week 0)2.845(0.8308)2.768(0.8103)
LDL cholesterol (calculated) at endpoint (week 26)2.738(0.8472)2.852(0.8134)
Triglycerides at baseline (week 0)2.391(1.5497)2.410(1.4398)
Triglycerides at endpoint (week 26)2.234(1.1886)2.006(1.2040)
Change in Body Weightkg · Baseline and 26 weeks · least squares mean
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
-4.10(0.22)1.02(0.22)
Change in Body Mass Index (BMI)kg/m^2 · Baseline and 26 weeks · least squares mean
Exenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
-1.39(0.07)0.32(0.07)
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)scores on DTSQ scale · Baseline and 26 weeks · mean
MeasureExenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
DTSQ score at baseline (week 0)29.5(6.13)29.7(6.25)
DTSQ score at endpoint (week 26)30.6(6.05)29.3(6.59)
Patient Reported Outcomes: Quality of Life (SF-12)scores on SF-12 scale · Baseline and 26 weeks · mean
MeasureExenatide Twice Dailyn=181Premixed Insulin Aspart Twice Dailyn=173
Physical Component at baseline (week 0)35.5(13.99)36.3(14.45)
Physical Component at endpoint (week 26)39.1(14.30)37.7(14.28)
Mental Component at baseline (week 0)31.3(18.33)28.3(19.43)
Mental Component at endpoint (week 26)31.1(19.38)29.6(18.36)
The trial

How NCT00434954 was run

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

  • Exenatide Twice Daily (BID)
  • Premixed Insulin Aspart Twice Daily (BID)
Who could join the trial

Inclusion Criteria: * Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start * Have an HbA1c between 6.5% and 10.0%, inclusive * Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive Exclusion Criteria: * Have type 1 diabetes or known latent autoimmune diabetes in adults * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start * Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics) * Have used any prescription drug to promote weight loss within 3 months prior to study start * Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry * Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs

Published papers

Papers from NCT00434954

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

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