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Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 diabetes
  • Fasting c-peptide below lower limit of normal fasting range
  • Duration of type 1 diabetes for at least 12 months
  • Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
  • HbA1c maximum 9.0% (using Biorad Variant method)
  • Able and willing to perform self-monitoring of blood glucose
  • Basal insulin requirement at least 30% of the total daily insulin dose
  • BMI (body Mass Index) maximum 35 kg/m^2

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Total daily insulin dose above 1.4 IU/kg/day
  • Known unawareness of hypoglycaemia
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled, treated/untreated hypertension
  • Known or suspected allergy to trial product or related products

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Detemir

NPH

Arm Description

Outcomes

Primary Outcome Measures

Incidence of total self-recorded hypoglycaemic episodes

Secondary Outcome Measures

Incidence of total major hypoglycaemic episodes
HbA1c (glycosylated haemoglobin)
8-point plasma glucose profiles
Serum glucose profiles
72-hours glucose profile
Within-subject variation in home-measured fasting plasma glucose
Incidence of adverse events

Full Information

First Posted
September 28, 2012
Last Updated
January 26, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01697657
Brief Title
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
Official Title
A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control 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 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Detemir
Arm Type
Experimental
Arm Title
NPH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Primary Outcome Measure Information:
Title
Incidence of total self-recorded hypoglycaemic episodes
Secondary Outcome Measure Information:
Title
Incidence of total major hypoglycaemic episodes
Title
HbA1c (glycosylated haemoglobin)
Title
8-point plasma glucose profiles
Title
Serum glucose profiles
Title
72-hours glucose profile
Title
Within-subject variation in home-measured fasting plasma glucose
Title
Incidence of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes Fasting c-peptide below lower limit of normal fasting range Duration of type 1 diabetes for at least 12 months Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections HbA1c maximum 9.0% (using Biorad Variant method) Able and willing to perform self-monitoring of blood glucose Basal insulin requirement at least 30% of the total daily insulin dose BMI (body Mass Index) maximum 35 kg/m^2 Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Total daily insulin dose above 1.4 IU/kg/day Known unawareness of hypoglycaemia Impaired hepatic function Impaired renal function Cardiac problems Uncontrolled, treated/untreated hypertension Known or suspected allergy to trial product or related products
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
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Ashford
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Citta' Di Castello
ZIP/Postal Code
06012
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Trelleborg
ZIP/Postal Code
231 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16842476
Citation
Kolendorf K, Ross GP, Pavlic-Renar I, Perriello G, Philotheou A, Jendle J, Gall MA, Heller SR. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med. 2006 Jul;23(7):729-35. doi: 10.1111/j.1464-5491.2006.01862.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

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