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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


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.


Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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