Acute Metabolic Effects of LAF 237 in Type 2 Diabetics

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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 inactivated by DPP-4. LAF 237 is an inhibitor of DPP-4 that has been shown to increase meal-stimulated levels of intact GLP-1 in animals and patients with T2DM.. The purpose of the current study is to explore the acute effects of LAF237 on the rate of appearance and disappearance of glucose in type 2 diabetics. Secondary objectives include the effect on FPG, insulin secretion rates, glucagon and FFA levels, and rate of glucose entry from the GI tract.

Key facts

Study ID

NCT00230464

Run by

The University of Texas Health Science Center at San Antonio

People needed

16

Starts

2004-11-01

Expected to finish

2005-09-01

Last updated by the study team

2006-01-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Audie L Murphy VA Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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