Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

NCT00795600 | Completed Phase 4 Results

• 2 other identifiers: NN304-36142008-003739-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)

  Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.

  week 0, week 26

• Absolute Change in Trunk Fat Mass

  Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.

  week 0, week 26

Secondary Outcomes (54)

• Absolute Change in Whole Body Fat Mass

  Week 0, week 26

• Percentage Change in Whole Body Fat Mass

  Week 0, week 26

• Absolute Change in Whole Body Lean Mass

  Week 0, week 26

• Percentage Change in Whole Body Lean Mass

  Week 0, week 26

• Absolute Change in Trunk Lean Mass

  Week 0, week 26

Study Arms (2)

insulin detemir

EXPERIMENTAL

Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks

Drug: insulin detemir

insulin NPH

ACTIVE COMPARATOR

Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks

Drug: insulin NPH

Interventions

insulin detemir DRUG

Insulin detemir once daily plus insulin aspart at mealtime

insulin detemir

insulin NPH DRUG

Insulin NPH once daily plus insulin aspart at mealtime

insulin NPH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
• Body Mass Index (BMI) between 27.5-40 kg/m\^2

You may not qualify if:

• Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
• Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
• Previous or planned surgical treatment of obesity
• Total daily insulin dose higher or equal 2 IU/kg
• Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
• Receipt of any investigational drug within 1 month prior to this trial
• Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Málaga, 29009, Spain

Location

Related Publications (1)

• Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

  PMID: 33166419 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir; Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 16, 2016
• Results First Posted: June 17, 2013

Record last verified: 2016-02

Locations

ES (1)