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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01114542
First received: April 29, 2010
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: NN1250
Drug: insulin glargine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the NN1250 glucose infusion rate curve during one dosing interval at steady state [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin glargine glucose infusion rate curve during one dosing interval at steady state [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during one dosing interval at steady state for NN1250 and insulin glargine [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose NN1250 Drug: NN1250
Subjects will be randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence will consist of 2 periods of each 13 days. One dose once daily. The trial products will be administered subcutaneously (under the skin)
Active Comparator: Low dose insulin glargine Drug: insulin glargine
Subjects will be randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence will consist of 2 periods of each 13 days. One dose once daily. The trial products will be administered subcutaneously (under the skin)
Experimental: Middle dose NN1250 Drug: NN1250
Subjects will be randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence will consist of 2 periods of each 13 days. One dose once daily. The trial products will be administered subcutaneously (under the skin)
Active Comparator: Middle dose insulin glargine Drug: insulin glargine
Subjects will be randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence will consist of 2 periods of each 13 days. One dose once daily. The trial products will be administered subcutaneously (under the skin)
Experimental: High dose NN1250 Drug: NN1250
Subjects will be randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence will consist of 2 periods of each 13 days. One dose once daily. The trial products will be administered subcutaneously (under the skin)
Active Comparator: High dose insulin glargine Drug: insulin glargine
Subjects will be randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence will consist of 2 periods of each 13 days. One dose once daily. The trial products will be administered subcutaneously (under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus 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/m2
  • HbA1c lower than or equal to 10.0%

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior at trial start
  • 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 trial start (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114542

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Charlotte Granhall, MSc. PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01114542     History of Changes
Other Study ID Numbers: NN1250-1993, 2009-015897-36, U1111-1113-6772
Study First Received: April 29, 2010
Last Updated: June 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013