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

Rijnstate Hospital

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus Type II

Treatments

Drug: Lantus

Drug: Novomix 30

Drug: Novorapid and Amaryl

Study type

Interventional

Funder types

Other

Identifiers

NCT00151697

LTC 297-161104

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.