Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765817
• Other study ID #: H8O-US-GWCO
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2008
• Last updated: October 21, 2016
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGreece: Ethics CommitteeMexico: Ethics CommitteeIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have type 2 diabetes.

• Have been taking insulin glargine at a dose of =20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

1. metformin (stable dose for 6 weeks)

2. pioglitazone (stable dose for 6 weeks)

3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

• Have HbA1C between 7.1% and 10.5%, inclusive.

• Have a body mass index (BMI) =45 kg/m2.

• Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

• Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.

• Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.

• Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.

• Women who are breastfeeding.

• Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.

• Have had a kidney transplant or are currently on kidney dialysis.

• Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.

• Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.

• Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.

• Are currently on a weight-loss program or have been on one within 3 months of entering the study.

• Have had a blood transfusion or severe blood loss within 3 months of entering the study.

• Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.

• Have an irregular sleep cycle (for example, sleeping during the day and working during the night).

• Have a history of pancreatitis.

• Have received treatment with an experimental drug within 30 days of entering the study.

• If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.

• If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.

• If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• placebo
subcutaneous injection, twice a day
• exenatide
subcutaneous injection, twice a day, 10mcg

Locations

Country	Name	City	State
Greece	Research Site	Athens
Greece	Research Site	Thessaloniki
Israel	Research Site	Holon
Israel	Research Site	Kfar Sava
Israel	Research Site	Tel Hashomer
Mexico	Research Site	Coatzacoalcos
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Puerto Rico	Research Site	Carolina
Puerto Rico	Research Site	Hato Rey
Puerto Rico	Research Site	Ponce
Puerto Rico	Research Site	San Juan
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Guildford
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Livingston
United Kingdom	Research Site	Middlesbrough
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Torquay
United States	Research Site	Alburquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Bend	Oregon
United States	Research Site	Berkeley Heights	New Jersey
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buena Park	California
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Concord	California
United States	Research Site	Dallas	Texas
United States	Research Site	Des Moines	Iowa
United States	Research Site	Durham	North Carolina
United States	Research Site	El Paso	Texas
United States	Research Site	Fresno	California
United States	Research Site	Georgetown	Texas
United States	Research Site	Greenbrae	California
United States	Research Site	Hollywood	Florida
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kenosha	Wisconsin
United States	Research Site	La Mesa	California
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Lancaster	California
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Matairie	Louisiana
United States	Research Site	Minneapolis	Minnesota
United States	Research SIte	New York	New York
United States	Research Site	Northridge	California
United States	Research Site	Omaha	Nebraska
United States	Research Site	Palm Springs	California
United States	Research Site	Peoria	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Richmond	Virginia
United States	Research Site	Salinas	California
United States	Research Site	San Antonio	Texas
United States	Research Site	St Louis	Missouri
United States	Research SIte	Teaneck	New Jersey
United States	Research Site	Vancouver	Washington
United States	Research Site	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Greece,  Israel,  Mexico,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Hemoglobin (HbA1c)	Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.	baseline and 30 weeks	No
Secondary	Percentage of Patients Achieving HbA1c <=7%	Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).	baseline and 30 weeks	No
Secondary	Percentage of Patients Achieving HbA1c <=6.5%	Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).	baseline and 30 weeks	No
Secondary	Change in Fasting Serum Glucose	Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)	baseline and 30 weeks	No
Secondary	Change in 7-point Self-monitored Blood Glucose (SMBG) Profile	Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)	baseline and 30 weeks	No
Secondary	Change in Total Cholesterol	Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)	baseline and 30 weeks	No
Secondary	Change in Low Density Lipoprotein (LDL) Cholesterol	Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)	baseline and 30 weeks	No
Secondary	Change in High Density Lipoprotein (HDL) Cholesterol	Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)	baseline and 30 weeks	No
Secondary	Change in Triglycerides	Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)	baseline and 30 weeks	No
Secondary	Change in Body Weight	Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)	baseline and 30 weeks	No
Secondary	Change in Waist Circumference	Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)	baseline and 30 weeks	No
Secondary	Change in Daily Insulin Dose	Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)	baseline and 30 weeks	No
Secondary	Change in Daily Insulin Dose (on a Per Body Weight Basis)	Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)	baseline and 30 weeks	No
Secondary	Change in Systolic Blood Pressure (SBP)	Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)	baseline and 30 weeks	No
Secondary	Change in Diastolic Blood Pressure (DBP)	Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)	baseline and 30 weeks	No
Secondary	Minor Hypoglycemia Rate Per Year	Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).	baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30	No
Secondary	Percentage of Subjects Experiencing Minor Hypoglycemia	Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).	baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30	No