Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type-2 Diabetes; Healthy
Intervention: Vildagliptin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Novartis investigator site
Summary
The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon
secretion, using treatment observations of the overall glycemic response.
Clinical Details
Official title: A Double-blind, Placebo-controlled, Randomized, Cross-over Study to Evaluate the GLP-1-mediated and Non-GLP-1-mediated Effects of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects
Secondary outcome: Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Inclusion criteria - Type-2 Diabetes Patients
- Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and
who are in otherwise good health
- Must have been diagnosed with T2DM at least 6 months prior to screening, and whose
diabetes is controlled by diet and exercise alone or by stable dosage ( > 3 months)
of metformin
- HbA1c in the range of 6. 5% to 9% at screening
Inclusion Criteria - Healthy Volunteers
- Male or female subjects aged 30 to 75 years, determined to be in good health
- Normal oral glucose tolerance test (OGTT) at screening
- Age, gender and weight matched to subjects with T2DM
Exclusion Criteria:
Exclusion criteria - Type-2 Diabetes Patients
- A history of:
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms
of diabetes, e. g., Cushing's syndrome and acromegaly
- Acute metabolic diabetic complications (such as ketoacidosis or hyperosmolar state
(coma)) within the past 6 months
- Torsades de Pointes, ventricular tachycardia or ventricular fibrillation
- Any severe hypoglycemic episode within 3 months of screening
- Use of any of the following medications:
- Antihypertensive or lipid-lowering agents unless on a stable dose for at least 3
months prior to screening
- Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent
illness) within the past 6 months
- Chronic oral/intramuscular/intravenous corticosteroid treatment ( > 7 consecutive
days of treatment) within 8 weeks prior to screening
Exclusion Criteria - Healthy Volunteers
- First degree relative of an individual with T2DM
- History of gestational diabetes
- Use of any prescription medication within 1 month prior to dosing. Use of
over-the-counter medications or vitamins within 14 days prior to dosing.
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Investigator Site, Bad Lauterberg Im Harz, Germany
Novartis Investigator Site, Berlin, Germany
Additional Information
Starting date: February 2008
Last updated: November 5, 2009
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