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

Diabetes Mellitus Type II Clinical Trial

Official title:

New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151697
• Other study ID #: LTC 297-161104
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: August 8, 2011
• Start date: May 2005

Study information

• Verified date: August 2011
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Novomix 30

• Novorapid and Amaryl

• Lantus

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control based on HbA1c
Primary	Body weight
Secondary	8-point glucose day curve of three consecutive days
Secondary	24-hour glycemic control measured by continuous glucose monitoring for three consecutive days
Secondary	recorded number of hypoglycemic events per month
Secondary	waist circumference
Secondary	dexa measurements of body composition
Secondary	plasma lipid levels
Secondary	basal and stimulated C-peptide levels
Secondary	adverse effects