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Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
exenatide twice daily (BID)
premixed insulin aspart twice daily (BID)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, exenatide, Byetta, Amylin, Lilly

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exenatide Twice Daily (BID)

Premixed Insulin Aspart Twice Daily (BID)

Arm Description

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Percentage of Subjects Achieving HbA1c Target of < 6.5%
Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].
Percentage of Subjects Achieving HbA1c Target of < 7.0%
Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].
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)
Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].
7 Point Self-monitored Blood Glucose (SMBG) Profiles
7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).
Blood Lipid Levels
Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)
Change in Body Weight
Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)
Change in Body Mass Index (BMI)
Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.
Patient Reported Outcomes: Quality of Life (SF-12)
SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.

Full Information

First Posted
February 12, 2007
Last Updated
March 19, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00434954
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, exenatide, Byetta, Amylin, Lilly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide Twice Daily (BID)
Arm Type
Experimental
Arm Title
Premixed Insulin Aspart Twice Daily (BID)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide twice daily (BID)
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection (5 mcg or 10 mcg), twice a day
Intervention Type
Drug
Intervention Name(s)
premixed insulin aspart twice daily (BID)
Intervention Description
subcutaneous injection (titrated appropriately), twice a day
Primary Outcome Measure Information:
Title
Change in Glycosylated Hemoglobin (HbA1c)
Description
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Time Frame
Baseline and 26 weeks
Title
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
Description
Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving HbA1c Target of < 6.5%
Description
Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].
Time Frame
26 weeks
Title
Percentage of Subjects Achieving HbA1c Target of < 7.0%
Description
Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].
Time Frame
26 weeks
Title
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)
Description
Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]
Time Frame
26 weeks
Title
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
Description
Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].
Time Frame
26 weeks
Title
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Description
7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).
Time Frame
Baseline and 26 weeks
Title
Blood Lipid Levels
Description
Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)
Time Frame
Baseline and 26 weeks
Title
Change in Body Weight
Description
Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)
Time Frame
Baseline and 26 weeks
Title
Change in Body Mass Index (BMI)
Description
Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)
Time Frame
Baseline and 26 weeks
Title
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Description
Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.
Time Frame
Baseline and 26 weeks
Title
Patient Reported Outcomes: Quality of Life (SF-12)
Description
SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.
Time Frame
Baseline and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Bad Mergentheim
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bosenheim
Country
Germany
Facility Name
Research Site
City
Burghausen
Country
Germany
Facility Name
Research Site
City
Datteln
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Friedrichsthal
Country
Germany
Facility Name
Research Site
City
Hildesheim
Country
Germany
Facility Name
Research Site
City
Hirschhorn
Country
Germany
Facility Name
Research Site
City
Hohenmolsen
Country
Germany
Facility Name
Research Site
City
Jena
Country
Germany
Facility Name
Research Site
City
Lehrte
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Ludwigsburg
Country
Germany
Facility Name
Research Site
City
Mannheim
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Marktheidenfeld
Country
Germany
Facility Name
Research Site
City
Meissen
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Offenbach
Country
Germany
Facility Name
Research Site
City
Oschatz
Country
Germany
Facility Name
Research Site
City
Pohlheim
Country
Germany
Facility Name
Research Site
City
Regensburg
Country
Germany
Facility Name
Research Site
City
Riesa
Country
Germany
Facility Name
Research Site
City
Rodgau
Country
Germany
Facility Name
Research Site
City
Roding
Country
Germany
Facility Name
Research Site
City
Rosenheim
Country
Germany
Facility Name
Research Site
City
Schluchtern
Country
Germany
Facility Name
Research Site
City
Schwedt/Oder
Country
Germany
Facility Name
Research Site
City
Sinsheim
Country
Germany
Facility Name
Research Site
City
Speyer
Country
Germany
Facility Name
Research Site
City
Unterhaching
Country
Germany
Facility Name
Research Site
City
Volklingen
Country
Germany
Facility Name
Research Site
City
Wallerfing
Country
Germany
Facility Name
Research Site
City
Wangen
Country
Germany
Facility Name
Research Site
City
Warburg
Country
Germany
Facility Name
Research Site
City
Wiesbaden
Country
Germany
Facility Name
Research Site
City
Wolfsburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22913891
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.
Results Reference
derived
PubMed Identifier
21285388
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.
Results Reference
derived

Learn more about this trial

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

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