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OpenTrials
Completed

NCT Number: NCT00651105

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

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigator Site, Bad Lauterberg im Harz, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vildagliptin

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
First posted
Apr 2, 2008
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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