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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

insulin degludec

insulin glargine

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 1 diabetes mellitus (as diagnosed clinically) 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/m^2

Exclusion Criteria:

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
Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

IDeg 0.4 U/kg

IDeg 0.6 U/kg

IDeg 0.8 U/kg

IGlar 0.4 U/kg

IGlar 0.6 U/kg

IGlar 0.8 U/kg

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state

Secondary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state

Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec

Area under the concentration-time curve during one dosing interval at steady state for insulin glargine

Full Information

NCT ID

NCT01114542

First Posted

April 29, 2010

Last Updated

October 6, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01114542

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

May 3, 2010 (Actual)

Primary Completion Date

August 10, 2010 (Actual)

Study Completion Date

August 10, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDeg 0.4 U/kg

Arm Type

Experimental

Arm Title

IDeg 0.6 U/kg

Arm Type

Experimental

Arm Title

IDeg 0.8 U/kg

Arm Type

Experimental

Arm Title

IGlar 0.4 U/kg

Arm Type

Active Comparator

Arm Title

IGlar 0.6 U/kg

Arm Type

Active Comparator

Arm Title

IGlar 0.8 U/kg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

insulin glargine

Intervention Description

Primary Outcome Measure Information:

Title

Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state

Time Frame

0-24 hours after dosing on day 8

Secondary Outcome Measure Information:

Title

Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state

Time Frame

0-24 hours after dosing on day 8

Title

Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec

Time Frame

0-24 hours after dosing on day 8

Title

Area under the concentration-time curve during one dosing interval at steady state for insulin glargine

Time Frame

0-24 hours after dosing on day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) 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/m^2 Exclusion Criteria: 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 Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25581159

Citation

Heise 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.

Results Reference

result

PubMed Identifier

26086190

Citation

Heise T, Hovelmann U, Nosek L, Hermanski L, Bottcher SG, Haahr H. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11(8):1193-201. doi: 10.1517/17425255.2015.1058779. Epub 2015 Jun 18.

Results Reference

result

PubMed Identifier

28946756

Citation

Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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