Status:
COMPLETED
Acute Metabolic Effects of LAF 237 in Type 2 Diabetics
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Incretin hormones (GIP and GLP-1) stimulate insulin release in a glucose dependant manner, hence are necessary for maintenance of normal glucose tolerance. Both GIP and GLP-1 are degraded and inactiva...
Detailed Description
Study Design Double blind, placebo-controlled, randomized, two -period crossover study. Sixteen (16) both sexes diabetic patients will be enrolled and randomized to receive one of two treatment sequen...
Eligibility Criteria
Inclusion
- Age 18-75 years with type 2 diabetes, males or females (non-pregnant)
- Time of diagnosis: within 6 months prior to screening, or 1 month prior to screening with no detectable anti-GAD Abs
- Normal physical exam, EKG, blood tests, and urinalysis
- HbA1c=7-11% at screening
- FPG=160-280 mg/dl at screening
- Diabetes controlled by diet and exercise alone or by stable dosage of metformin or sulfonylurea
- BMI=22-45 kg/m2 and with a stable (+/- 2.5 kg) weight for the last 6 months
- Compliant to study requirements \& written consent.
Exclusion
- Pregnant or lactating female
- History of: type 1 DM, pancreatic injury, secondary diabetes (Cushing, acromegaly), acute metabolic complications (ketoacidosis or hyperosmolar state) within the past 6 months, torsades des pointes, ventricular tachycardia or ventricular fibrillation
- Any of the following within the past 6 months: MI, CABG, unstable angina
- ECG abnormalities: second degree AV block (Mobitz 1 and 2), third degree AV block, prolonged QTc (\>450 ms)
- Use of the following medications: class Ia ,Ib, Ic or III antiarrhythmics, insulin, thiazolidinediones, corticosteroids
- Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
- Fasting triglycerides \>700 mg/dl at screening
- Diabetic complications
- Renal disease (creatinine \>1.5 mg/dl-males or \>1.4 mg/dl-female), renal failure, hepatic dysfunction, thyrotoxicosis
- History of gastrointestinal surgery (partial bowel resections, partial gastric resections)
- Donation of one unit of blood within 2 weeks or transfusion within 8 weeks prior to screening
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00230464
Start Date
November 1 2004
End Date
September 1 2005
Last Update
January 4 2006
Active Locations (1)
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1
Audie L Murphy VA Hospital
San Antonio, Texas, United States, 78229