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Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Austria

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
Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IDeg

IGlar

Arm Description

Outcomes

Primary Outcome Measures

Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration

Secondary Outcome Measures

Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose

Time from start of hypoglycaemic induction until each level of plasma glucose is reached

Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L

Hypoglycaemic symptoms score during recovery from hypoglycaemia

Full Information

NCT ID

NCT01002768

First Posted

October 26, 2009

Last Updated

January 19, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01002768

Brief Title

Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

Official Title

A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 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 iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes. The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

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

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDeg

Arm Type

Experimental

Arm Title

IGlar

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

Intervention Type

Drug

Intervention Name(s)

insulin glargine

Intervention Description

Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

Primary Outcome Measure Information:

Title

Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration

Time Frame