Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes

NCT00506662 | Terminated Phase 4 Results

• 2 other identifiers: NN304-18082006-006589-41
• Study Type: interventional
• Target: 86
• Locations: 2 countries
• Sites: 2

Brief Summary

This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Haemoglobin (HbA1c) at Month 7

  week 0, month 7

Secondary Outcomes (12)

• Change in Glycosylated Haemoglobin (HbA1c) at Month 4

  week 0, month 4

• Change in Mean Fasting Plasma Glucose (FPG) at Month 7

  week 0, month 7

• Change in Mean Fasting Plasma Glucose (FPG) at Month 4

  week 0, month 4

• Change in Mean Pre-lunch Plasma Glucose at Month 7

  week 0, month 7

• Change in Mean Pre-lunch Plasma Glucose at Month 4

  week 0, month 4

Study Arms (2)

Insulin detemir

EXPERIMENTAL

Individually adjusted dose of insulin detemir once daily

Drug: insulin detemir

Insulin NPH

ACTIVE COMPARATOR

Individually adjusted dose of insulin NPH once daily

Drug: insulin NPH

Interventions

insulin detemir DRUG

Treat-to-target, s.c. (under the skin) injection, once daily

Insulin detemir

insulin NPH DRUG

Treat-to-target, s.c. (under the skin) injection, once daily

Insulin NPH

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Insulin naive
• Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
• HbA1c between 8% - 10.5%

You may not qualify if:

• Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
• Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
• Proliferative retinopathy, maculopathy requiring treatment,
• Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
• End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
• Acute disease with poor prognosis
• History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
• Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator
• Legal incapacity or limited legal capacity (patients under guardianship or curatorship)
• Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment)
• Illness requiring repeated hospitalisation
• Known or suspected allergy to the insulin or any compositional component
• Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
• Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
• Terminal illness

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Unknown Facility

Paris La Défense, 92936, France

Location

Unknown Facility

Cambridge, CB2 2QQ, United Kingdom

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

Limitations and Caveats

Trial terminated prematurely due to low recruitment, and thus it was not possible to assess efficacy in this trial due to the small number of patients in each treatment group.

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: July 24, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 14, 2023
• Results First Posted: November 17, 2010

Record last verified: 2023-08

Locations

GB (1); FR (1)