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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

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ClinicalTrials.gov Identifier: NCT00964964
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin degludec Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: SIBA 3W Drug: insulin degludec
Insulin degludec injected s.c. (under the skin) three times weekly
Drug: placebo
Placebo injected s.c. (under the skin) four times weekly
Experimental: SIBA OD Drug: insulin degludec
Insulin degludec injected s.c. (under the skin) once daily for one week


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964964


Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00964964     History of Changes
Other Study ID Numbers: NN1250-3765
2009-011959-53 ( EudraCT Number )
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

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