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

Overview[ - collapse ][ - ]

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.
ConditionDiabetes Mellitus Type II
InterventionDrug: Novomix 30
Drug: Novorapid and Amaryl
Drug: Lantus
PhasePhase 3
SponsorRijnstate Hospital
Responsible PartyRijnstate Hospital
ClinicalTrials.gov IdentifierNCT00151697
First ReceivedSeptember 8, 2005
Last UpdatedAugust 8, 2011
Last verifiedAugust 2011

Tracking Information[ + expand ][ + ]

First Received DateSeptember 8, 2005
Last Updated DateAugust 8, 2011
Start DateMay 2005
Estimated Primary Completion DateNot Provided
Current Primary Outcome Measures
  • glycemic control based on HbA1c
  • Body weight
Current 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

Descriptive Information[ + expand ][ + ]

Brief TitleLANN-study: Lantus, Amaryl, Novorapid, Novomix Study
Official TitleNew Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment
Brief 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.
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.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus Type II
InterventionDrug: Novomix 30
Drug: Novorapid and Amaryl
Drug: Lantus
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment150
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility 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.
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNetherlands

Administrative Information[ + expand ][ + ]

NCT Number NCT00151697
Other Study ID NumbersLTC 297-161104
Has Data Monitoring CommitteeNot Provided
Information Provided ByRijnstate Hospital
Study SponsorRijnstate Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Hans de Boer, MD, PhD Rijnstate Hospital
Verification DateAugust 2011

Locations[ + expand ][ + ]

Rijnstate Hospital
Arnhem, Netherlands, 6800 TA