Trial record 9 of 42 for:
Open Studies | "Hypoglycemic Agents"
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
This study is currently recruiting participants.
Verified July 2012 by Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
First received: April 8, 2008
Last updated: July 24, 2012
Last verified: July 2012
The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetic agents(with diet and exercise) or who are being treated with Met, SU, or a combination of Met and SU (with or without diet and exercise).
Type 2 Diabetes
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Primary Outcome Measures:
- The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Exenatide 5 µg BID vs. Exenatide 10 µg BID vs. placebo to compare: • the proportion of patients achieving an HbA1c at endpoint of ≤7%, <7%, ≤6.5% and <6.5% • body weight • fasting serum glucose • self-monitored blood glucose [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: 1
subcutaneous injection, twice a day
Active Comparator: 2
subcutaneous injection, twice a day, 10 mcg
Active Comparator: 3
subcutaneous injection, twice a day, 5 mcg
|Ages Eligible for Study:
||10 Years to 17 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Are between ages 10 to 17 years, inclusive.
- Have a history of type 2 diabetes.
- Have no antibodies to glutamic decarboxylase (GAD65) or islet cell (ICA512).
- Have been treated with Met, an SU, or both Met and SU (with or without diet and exercise), for at least 3 months or are naïve to antidiabetic agents (with diet and exercise). The dose of oral agent(s) should be stable for the 30 days prior to the screening visit.
- Have HbA1c between 6.5% and 10.5%, inclusive.
- Present an appropriately signed assent form.
- A parent or adult guardian agrees in writing to participate in the patient's treatment by signing a consent form.
- Both the patient and parent or responsible adult guardian are able to understand and comply with a lifestyle modification program.
- Received any investigational drug or has participated in any type of clinical trial within 60 days prior to screening.
- Have previously been exposed to exenatide or, completed or withdrawn from any study investigating exenatide.
- Are unwilling or unable to inject the study medication.
- Have a genetic syndrome or disorder other than diabetes known to affect glucose tolerance.
- Have used an alpha-glucosidase inhibitor, a meglitinide, or pramlintide for more than 1 week during the 3 months prior to screening.
- Currently use inhaled steroids at a dose equal to or above 1000 μg Flovent® (fluticasone propionate) daily.
- Have used oral steroids within the last 60 days or more than 20 days use within the past year.
- Have used a TZD within 120 days prior to screening.
- Have used any weight loss medication(s) within 30 days of screening.
- Are sexually active female of childbearing potential who is unwilling to appropriately use TWO methods of birth control (for example, use of oral contraceptives; condoms with contraceptive foam; or abstinence) for the duration of the study.
- Are female who is pregnant or planning to become pregnant within 6 months of study screening.
- Are female who is lactating.
- Have had at least one episode of diabetic ketoacidosis (DKA) after receiving antidiabetes medication. A history of DKA at the time of diagnosis will not be an exclusion criterion.
- Have physical limitations that prevent participation in lifestyle intervention.
- Have admitted use of anabolic steroids within the past 60 days.
- Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than in situ carcinomas of the cervix) for less than 5 years.
- Have used insulin for more than 10 weeks during the 3 months prior to screening.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658021
|Contact: Lilly Clinical Trials Support Center
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
||Chief Medical Officer, MD
||Eli Lilly and Company
No publications provided
||Amylin Pharmaceuticals, LLC.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 8, 2008
||July 24, 2012
||United States: Food and Drug Administration
Keywords provided by Amylin Pharmaceuticals, LLC.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs