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Completed

NCT Number: NCT00434954

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Bad Mergentheim, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide twice daily (BID)

Drug

subcutaneous injection (5 mcg or 10 mcg), twice a day

Other names: Byetta

premixed insulin aspart twice daily (BID)

Drug

subcutaneous injection (titrated appropriately), twice a day

Primary outcomes

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline and 26 weeks

    Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)

  2. Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)

    Time frame: 26 weeks

    Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26

Secondary outcomes

  1. Percentage of Subjects Achieving HbA1c Target of < 6.5%

    Time frame: 26 weeks

    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%].

  2. Percentage of Subjects Achieving HbA1c Target of < 7.0%

    Time frame: 26 weeks

    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%].

  3. 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)

    Time frame: 26 weeks

    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%]

  4. Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)

    Time frame: 26 weeks

    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%].

  5. 7 Point Self-monitored Blood Glucose (SMBG) Profiles

    Time frame: Baseline and 26 weeks

    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).

  6. Blood Lipid Levels

    Time frame: Baseline and 26 weeks

    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)

  7. Change in Body Weight

    Time frame: Baseline and 26 weeks

    Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)

  8. Change in Body Mass Index (BMI)

    Time frame: Baseline and 26 weeks

    Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)

  9. Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: Baseline and 26 weeks

    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.

  10. Patient Reported Outcomes: Quality of Life (SF-12)

    Time frame: Baseline and 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 14, 2007
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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