LANN-study: Lantus, Amaryl, Novorapid, Novomix Study - Full Text View

Sponsor:	Rijnstate Hospital
Information provided by:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00151697

Purpose

Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.

Condition	Intervention	Phase
Diabetes Mellitus Type II	Drug: Novomix 30 Drug: Novorapid and Amaryl Drug: Lantus	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glimepiride Insulin aspart Insulin glargine

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:

glycemic control based on HbA1c
Body weight

Secondary Outcome Measures:

8-point glucose day curve of three consecutive days
24-hour glycemic control measured by continuous glucose monitoring for three consecutive days
recorded number of hypoglycemic events per month
waist circumference
dexa measurements of body composition
plasma lipid levels
basal and stimulated C-peptide levels
adverse effects

Estimated Enrollment:	150
Study Start Date:	May 2005

Detailed Description:

Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally accompanied by a substantial gain in body weight. This may lead to an increase in body fat resulting in a worsening of insulin resistance, leading to an increase in insulin dose needed to maintain glycemic control.

The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.

In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus. Metformin will be continued.

In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and HbA1C over 7.5% for three months or more
BMI 25 - 35 kg/m2
fasting plasma C-peptide level over 0.3 nmol/l
stable metformin and sulfonylurea dose for at least three months
stable weight for at least three months (change maximal 2 kg)

Exclusion Criteria:

fasting glucose over 25 mmol/l
use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
heart failure
pregnancy
alcohol more than two units per day
inflammatory or infectious diseases
unstable chronic disease
discontinuation of smoking within three months of randomisation date
allergy for or intolerance of glimepiride or novorapid.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151697

Locations

Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA

Sponsors and Collaborators

Rijnstate Hospital

Investigators

Principal Investigator:

Hans de Boer, MD, PhD

Rijnstate Hospital

More Information

Publications:

de Boer H, Jansen M, Koerts J, Verschoor L. Prevention of weight gain in type 2 diabetes requiring insulin treatment. Diabetes Obes Metab. 2004 Mar;6(2):114-9.

ClinicalTrials.gov Identifier:	NCT00151697 History of Changes
Other Study ID Numbers:	LTC 297-161104
Study First Received:	September 8, 2005
Last Updated:	August 8, 2011
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:

diabetes
failing oral treatment
weight gain

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin aspart
Glargine

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012