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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697657
• Other study ID #: NN304-1375
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2012
• Last updated: January 26, 2017
• Start date: September 2001
• Est. completion date: November 2002

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir
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
• insulin NPH
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
• insulin aspart
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

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Ashford
Australia	Novo Nordisk Investigational Site	Box Hill
Australia	Novo Nordisk Investigational Site	Camperdown	New South Wales
Croatia	Novo Nordisk Investigational Site	Zagreb
Denmark	Novo Nordisk Investigational Site	Århus C
Denmark	Novo Nordisk Investigational Site	Køge
Italy	Novo Nordisk Investigational Site	Citta' Di Castello
Italy	Novo Nordisk Investigational Site	Perugia
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
Sweden	Novo Nordisk Investigational Site	Linköping
Sweden	Novo Nordisk Investigational Site	Trelleborg

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Croatia,  Denmark,  Italy,  South Africa,  Sweden, 

References & Publications (1)

Kølendorf 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of total self-recorded hypoglycaemic episodes
Secondary	Incidence of total major hypoglycaemic episodes
Secondary	HbA1c (glycosylated haemoglobin)
Secondary	8-point plasma glucose profiles
Secondary	Serum glucose profiles
Secondary	72-hours glucose profile
Secondary	Within-subject variation in home-measured fasting plasma glucose
Secondary	Incidence of adverse events

External Links

•   Clinical Trials at Novo Nordisk