A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00360334
First received: August 2, 2006
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.


Condition Intervention Phase
Type 2 Diabetes
Drug: exenatide
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Composite endpoint evaluating effect of treatment on glycemic control and weight


Secondary Outcome Measures:
  • Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Composite endpoint evaluating effect of treatment on glycemic control and weight

  • Change in Fasting Serum Glucose [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)

  • Percent of Patients Achieving HbA1c ≤ 7.4% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of patients achieving specified HbA1c target at endpoint

  • Percent of Patients Achieving HbA1c < 7% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of patients achieving specified HbA1c target at endpoint

  • Percent of Patients Achieving HbA1c < 6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of patients achieving specified HbA1c target at endpoint

  • Change in 7 Point Self Monitored Blood Glucose Profile [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day

  • Change in Body Mass Index (BMI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in BMI from baseline to endpoint

  • Change in Waist Circumference [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
    Change in waist circumference from baseline to endpoint

  • Change in Waist-to-hip Ratio [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in waist-to-hip ratio from baseline to endpoint

  • Change in Body Weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline to endpoint

  • Percent Change in Body Weight [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
    Percent change in baseline body weight at endpoint

  • Percent of Patients Achieving 5% Weight Loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of patients who lost at least 5% of baseline body weight at endpoint

  • Percent of Patients Achieving 10% Weight Loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of patients who lost at least 10% of baseline body weight at endpoint

  • Change in Systolic Blood Pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in systolic blood pressure from baseline to endpoint

  • Change in Diastolic Blood Pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in diastolic blood pressure from baseline to endpoint

  • Change in Fasting Serum Total Cholesterol (TC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in TC from baseline to endpoint

  • Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in HDL cholesterol from baseline to endpoint

  • Change in TC to HDL Cholesterol Ratio [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in TC to HDL cholesterol ratio from baseline to endpoint

  • Change in Fasting Serum Triglycerides [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in fasting serum triglycerides from baseline to endpoint

  • Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in LDL cholesterol from baseline to endpoint

  • Change in Apolipoprotein-B [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in apolipoprotein-B from baseline to endpoint

  • Incidence of Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study

  • Incidence of Nocturnal Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study

  • Incidence of Severe Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study

  • Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Number of hypoglycemic episodes per patient adjusted per 30 days

  • Nocturnal Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days

  • Severe Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Number of severe hypoglycemic episodes per patient adjusted per 30 days


Enrollment: 235
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Name: Byetta
Active Comparator: 2 Drug: insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day
Other Name: Lantus

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
  • HbA1c between 7.5% and 10.0%.
  • BMI >27.

Exclusion Criteria:

  • Receive 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 study.
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
  • Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360334

Locations
United Kingdom
Research Site
Aberdeen, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Blackburn, United Kingdom
Research Site
Bolton, United Kingdom
Research Site
Bournemouth, United Kingdom
Research Site
Bristol, United Kingdom
Research Site
Chippenham, United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Haywards Heath, United Kingdom
Research Site
High Wycombe, United Kingdom
Research Site
Hull, United Kingdom
Research Site
Ipswich, United Kingdom
Research Site
Kent, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
Livingstone, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Middlesborough, United Kingdom
Research Site
Norwich, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Oldham, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Plymouth, United Kingdom
Research Site
Rochdale, United Kingdom
Research Site
Salford, United Kingdom
Research Site
Swansea, United Kingdom
Research Site
Torquay, United Kingdom
Research Site
Wakefield, United Kingdom
Research Site
Wirral, United Kingdom
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Mauricio Silva de Lima, MD Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00360334     History of Changes
Other Study ID Numbers: H8O-BP-GWBG
Study First Received: August 2, 2006
Results First Received: April 14, 2009
Last Updated: June 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
diabetes
exenatide
insulin glargine
Lilly
Amylin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin, Globin Zinc
Exenatide
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 15, 2014