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

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
|
- 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 ]
- 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 ]
- 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 ]

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

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
Germany | |
Neuss, Germany, 41460 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
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 |