Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
1 other identifier
interventional
494
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Feb 2007
Typical duration for phase_3 type-2-diabetes-mellitus
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
August 23, 2010
CompletedApril 7, 2015
March 1, 2015
2.3 years
February 12, 2007
June 25, 2010
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Baseline and 26 weeks
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26
26 weeks
Secondary Outcomes (10)
Percentage of Subjects Achieving HbA1c Target of < 6.5%
26 weeks
Percentage of Subjects Achieving HbA1c Target of < 7.0%
26 weeks
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)
26 weeks
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
26 weeks
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Baseline and 26 weeks
- +5 more secondary outcomes
Study Arms (2)
Exenatide Twice Daily (BID)
EXPERIMENTALPremixed Insulin Aspart Twice Daily (BID)
ACTIVE COMPARATORInterventions
subcutaneous injection (5 mcg or 10 mcg), twice a day
subcutaneous injection (titrated appropriately), twice a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (39)
Research Site
Bad Mergentheim, Germany
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Berlin, Germany
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Bosenheim, Germany
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Burghausen, Germany
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Datteln, Germany
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Dresden, Germany
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Essen, Germany
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Friedrichsthal, Germany
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Hildesheim, Germany
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Hirschhorn, Germany
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Hohenmölsen, Germany
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Jena, Germany
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Lehrte, Germany
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Leipzig, Germany
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Ludwigsburg, Germany
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Mannheim, Germany
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Marburg, Germany
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Marktheidenfeld, Germany
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Meissen, Germany
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München, Germany
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Offenbach, Germany
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Oschatz, Germany
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Pohlheim, Germany
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Regensburg, Germany
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Riesa, Germany
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Rodgau, Germany
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Roding, Germany
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Rosenheim, Germany
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Schlüchtern, Germany
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Schwedt, Germany
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Sinsheim, Germany
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Speyer, Germany
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Unterhaching, Germany
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Völklingen, Germany
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Wallerfing, Germany
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Wangen, Germany
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Warburg, Germany
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Wiesbaden, Germany
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Wolfsburg, Germany
Related Publications (2)
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.
PMID: 22913891DERIVEDGallwitz 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.
PMID: 21285388DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Chief Medical Officer, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 14, 2007
Study Start
February 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
April 7, 2015
Results First Posted
August 23, 2010
Record last verified: 2015-03