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 study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00964964
First received: August 24, 2009
Last updated: November 26, 2013
Last verified: November 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin degludec Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964964
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00964964 History of Changes |
| Other Study ID Numbers: | NN1250-3765 2009-011959-53 |
| Study First Received: | August 24, 2009 |
| Last Updated: | November 26, 2013 |
| 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 Insulin, Globin Zinc Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016