LANN-study: Lantus, Amaryl, Novorapid, Novomix Study

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00151697
First received: September 8, 2005
Last updated: August 8, 2011
Last verified: August 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Glargine
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin Aspart
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 31, 2014