Clinical trial NCT00434954: Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-02-14
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline and 26 weeks
measure: Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
timeFrame: 26 weeks
Secondary outcomes:
measure: Percentage of Subjects Achieving HbA1c Target of < 6.5%
timeFrame: 26 weeks
measure: Percentage of Subjects Achieving HbA1c Target of < 7.0%
timeFrame: 26 weeks
measure: 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)
timeFrame: 26 weeks
measure: Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
timeFrame: 26 weeks
measure: 7 Point Self-monitored Blood Glucose (SMBG) Profiles
timeFrame: Baseline and 26 weeks
measure: Blood Lipid Levels
timeFrame: Baseline and 26 weeks
measure: Change in Body Weight
timeFrame: Baseline and 26 weeks
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 26 weeks
measure: Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: Baseline and 26 weeks
measure: Patient Reported Outcomes: Quality of Life (SF-12)
timeFrame: Baseline and 26 weeks
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bosenheim
country: Germany
facility: Research Site
city: Burghausen
country: Germany
facility: Research Site
city: Datteln
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Friedrichsthal
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Hirschhorn
country: Germany
facility: Research Site
city: Hohenmolsen
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Lehrte
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Marktheidenfeld
country: Germany
facility: Research Site
city: Meissen
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Offenbach
country: Germany
facility: Research Site
city: Oschatz
country: Germany
facility: Research Site
city: Pohlheim
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Riesa
country: Germany
facility: Research Site
city: Rodgau
country: Germany
facility: Research Site
city: Roding
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Schluchtern
country: Germany
facility: Research Site
city: Schwedt/Oder
country: Germany
facility: Research Site
city: Sinsheim
country: Germany
facility: Research Site
city: Speyer
country: Germany
facility: Research Site
city: Unterhaching
country: Germany
facility: Research Site
city: Volklingen
country: Germany
facility: Research Site
city: Wallerfing
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Warburg
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Wolfsburg
country: Germany
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
citation: Gallwitz B, Bohmer M, Segiet T, Molle A, Milek K, Becker B, Helsberg K, Petto H, Peters N, Bachmann O. Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia. Diabetes Care. 2011 Mar;34(3):604-6. doi: 10.2337/dc10-1900. Epub 2011 Feb 1.