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Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects

Primary Purpose

Type-2 Diabetes, Healthy

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Vildagliptin

Placebo

About this trial

This is an interventional treatment trial for Type-2 Diabetes focused on measuring Diabetes, Hyperglycemia, Healthy, Vildagliptin, Adults

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Novartis Investigator Site
Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects

Secondary Outcome Measures

Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.

Full Information

NCT ID

NCT00651105

First Posted

March 28, 2008

Last Updated

November 16, 2016

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00651105

Brief Title

Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type-2 Diabetes, Healthy

Keywords

Diabetes, Hyperglycemia, Healthy, Vildagliptin, Adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects

Time Frame

from baseline to Day 10

Secondary Outcome Measure Information:

Title

Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.

Time Frame

10 day treatment periods

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis investigator site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigator Site

City

Bad Lauterberg im Harz

Country

Germany

Facility Name

Novartis Investigator Site

City

Berlin

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

27207543

Citation

Nauck MA, Kind J, Kothe LD, Holst JJ, Deacon CF, Broschag M, He YL, Kjems L, Foley J. Quantification of the Contribution of GLP-1 to Mediating Insulinotropic Effects of DPP-4 Inhibition With Vildagliptin in Healthy Subjects and Patients With Type 2 Diabetes Using Exendin [9-39] as a GLP-1 Receptor Antagonist. Diabetes. 2016 Aug;65(8):2440-7. doi: 10.2337/db16-0107. Epub 2016 Apr 5.

Results Reference

result

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Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects

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