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The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD

Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00521690
Enrollment
25
Registered
2007-08-28
Start date
2006-12-31
Completion date
2007-08-31
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.

Interventions

DRUGinsulin detemir

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes * HbA1C: 7.0-11.0% * Previous diabetes treatment for at least 6 months * BMI max. 35 kg/m2 * Treatment with an oral anti-diabetic drug (OAD)

Exclusion criteria

* Type 1 diabetes * Receipt of any investigational drug within the last three months prior to this trial

Design outcomes

Primary

MeasureTime frame
Incidence of serious adverse events, including major hypoglycaemic eventsduring 16 weeks of insulin detemir therapy

Secondary

MeasureTime frame
Change in HbA1Cafter 16 weeks
Change in weight
Change in fasting plasma glucose (FPG)
Incidence of hypoglycaemic episodes

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026