Clinical trial NCT00604344: Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
Official title: A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 401
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring diabetes.


Eligibility criteria: Inclusion Criteria:

* Duration of diabetes mellitus for at least 2 years
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
* HbA1C below 11.0%

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Serious heart diseases
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total insulin dose of more than 100 IU/day
* Current treatment or expected at the screening to start treatment with systemic corticosteroids

Primary outcomes:
measure: HbA1c
timeFrame: after 48 weeks of treatment
Secondary outcomes:
measure: Blood glucose profiles
measure: Hypoglycaemic episodes
measure: Adverse events
measure: Body weight
measure: Insulin antibodies
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 48-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Subjects with Insulin Requriring Diabetes Mellitus in a Basal-bolus Regimen. J. Japan Diab. Soc 2007; 50 (9): 649-663
citation: Kobayashi M, Iwamoto Y, Kawamori R, Tajima N, Nishida T, Kaku K. Insulin detemir achieves lower, less variable fasting glucose and a reduced risk of nocturnal hypoglycaemia and weight gain compared to NPH insulin in basal bolus therapy of Japanese patients with type 1 diabetes. Diabetologia 2006; 49 (Suppl 1): A608-A609 [Abstract 995]
citation: Ishii H, Iwamoto Y, Kaku K, Kawamori R, Tajima N, Kobayashi M. Quality of Life (QoL) Assessment of Insulin Detemir and NPH Human Insulin in Japanese Subjects with Diabetes on Basal-Bolus Regimen. Diabetes 2007; 56 (Suppl. 1): A170 (2805-PO)
citation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.