LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedAugust 9, 2011
August 1, 2011
September 8, 2005
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
glycemic control based on HbA1c
Body weight
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate Hospital
Arnhem, 6800 TA, Netherlands
Related 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. doi: 10.1111/j.1463-1326.2004.00322.x.
PMID: 14746576BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans de Boer, MD, PhD
Rijnstate Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 9, 2005
Study Start
May 1, 2005
Last Updated
August 9, 2011
Record last verified: 2011-08