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NCT Number: NCT01114542

A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

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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

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 (as diagnosed clinically) for at least 12 months
  • Current total daily insulin treatment lower than 1.2 (I)U/kg/day
  • Body mass index 18.0-28.0 kg/m^2

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Treatment and study plan

insulin degludec

Drug

Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

insulin glargine

Drug

Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

Primary outcomes

  1. Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state

    Time frame: 0-24 hours after dosing on day 8

Secondary outcomes

  1. Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state

    Time frame: 0-24 hours after dosing on day 8

  2. Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec

    Time frame: 0-24 hours after dosing on day 8

  3. Area under the concentration-time curve during one dosing interval at steady state for insulin glargine

    Time frame: 0-24 hours after dosing on day 8

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 3, 2010
Registry last updated
Oct 9, 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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