A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes
A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes
3 other identifiers
interventional
49
1 country
1
Brief Summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 30, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 20, 2017
January 1, 2017
5 months
June 30, 2010
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate curve from 0-24 hours at steady state
0-24 hours (derived on treatment day 6)
Secondary Outcomes (1)
Area under the insulin degludec concentration-time curve from 0-24 hours at steady state
0-24 hours (derived on treatment day 6)
Study Arms (4)
IDeg 100U/mL 0.4U/kg
EXPERIMENTALIDeg 100U/mL 0.6U/kg
EXPERIMENTALIDeg 100U/mL 0.8U/kg
EXPERIMENTALIDeg 200U/mL 0.6U/kg
EXPERIMENTALInterventions
Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Neuss, 41460, Germany
Related Publications (2)
Heise T, Nosek L, Bottcher SG, Hastrup H, Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab. 2012 Oct;14(10):944-50. doi: 10.1111/j.1463-1326.2012.01638.x. Epub 2012 Jul 10.
PMID: 22726241RESULTHeise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.
PMID: 25581159RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2010
First Posted
July 1, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 20, 2017
Record last verified: 2017-01