NCT00468364

Brief Summary

Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night in patients with diabetes. The aims of the study are 1) to compare the dynamic characteristics of long-acting insulin analog glargine with those of NPH insulin and placebo during the night and the early morning hours, 2) investigate differences on glucose metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
Last Updated

August 30, 2007

Status Verified

August 1, 2007

First QC Date

April 30, 2007

Last Update Submit

August 29, 2007

Conditions

Diabetes

Keywords

Hypoglycemia, bedtime insulin, long-acting insulin

Interventions

insulin glargineDRUG
NPH insulinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes mellitus
  • Therapy may be with either insulin alone or in combination with oral anti-diabetic agents
  • Metabolic control with HbA1c values \< 10%

You may not qualify if:

  • Other than type 2 diabetes
  • Pregnancy
  • Systemic Corticosteroids, Beta-blockers
  • Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematological or other major disease making implementation of the protocol or interpretation of the study results difficult
  • History of drug or alcohol abuse
  • Impaired renal function (serum creatinine \> 1.3 mg/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit

Giessen, 35392, Germany

Location

Related Publications (1)

  • Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M, Vahatalo M, Virtamo H, Nikkila K, Tulokas T, Hulme S, Hardy K, McNulty S, Hanninen J, Levanen H, Lahdenpera S, Lehtonen R, Ryysy L. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006 Mar;49(3):442-51. doi: 10.1007/s00125-005-0132-0. Epub 2006 Feb 3.

    PMID: 16456680BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Interventions

Insulin GlargineInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas Linn, MD

    Justus Liebig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

July 1, 2003

Study Completion

March 1, 2006

Last Updated

August 30, 2007

Record last verified: 2007-08

Locations

DE(1)