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Completed

NCT Number: NCT00359879

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Campinas, Brazil

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 2 diabetes.
  • Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
  • HbA1c between 7.1% and 10.0%, inclusive.
  • Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2

Exclusion criteria

  • Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
  • Have characteristics contraindicating metformin, SU, or TZD use.
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
  • Have used any prescription drug to promote weight loss within 3 months prior to screening.
  • Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)

Other names: Byetta

Primary outcomes

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

    Time frame: Baseline, Week 12

    Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12

Secondary outcomes

  1. Change in body weight from Baseline to Week 12, and if measured, at each visit

    Time frame: Baseline, Weeks 4, 8, 12

    Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

  2. Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit

    Time frame: Baseline, Weeks 4, 8, 12

    Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

  3. Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12

    Time frame: Baseline, Weeks 4, 8, 12

    Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 3, 2006
Registry last updated
Feb 23, 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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