Skip to main content
OpenTrials
Completed

NCT Number: NCT00964964

A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics

This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes mellitus for at least 12 months
  • Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)

Exclusion criteria

  • Donation or loss of more than 500 ml blood or plasma within three months prior to this trial
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
  • Prior or current treatment with metformin or thiazolidinediones

Treatment and study plan

insulin degludec

Drug

Insulin degludec injected s.c. (under the skin) three times weekly

Placebo

Drug

Placebo injected s.c. (under the skin) four times weekly

Primary outcomes

  1. Total number of periods where carbohydrate supplementation is needed during the treatment

    Time frame: Assessed every day of the two in-house stays of nine days

Secondary outcomes

  1. Frequency of adverse events (AEs)

    Time frame: Assessed every day of the two in-house stays of nine days and one follow-up by telephone

  2. Number of periods with low blood sugar during treatment

    Time frame: Assessed every day of the two in-house stays of nine days and one follow-up by telephone

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml in Subjects With Type 1 Diabetes

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2009
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.