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OpenTrials
Completed

NCT Number: NCT01002768

Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

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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

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

Treatment and study plan

insulin degludec

Drug

Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

insulin glargine

Drug

Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

Primary outcomes

  1. Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration

    Time frame: Within 0-46 hours after last trial product administration

Secondary outcomes

  1. Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose

    Time frame: Within 0-46 hours after last trial product administration

  2. Time from start of hypoglycaemic induction until each level of plasma glucose is reached

    Time frame: Within 0-46 hours after last trial product administration

  3. Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L

    Time frame: Within 0-46 hours after last trial product administration

  4. Hypoglycaemic symptoms score during recovery from hypoglycaemia

    Time frame: Within 0-46 hours after last trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Jan 20, 2017

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.

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