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Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00184626
Enrollment
97
Registered
2005-09-16
Start date
2004-09-10
Completion date
2005-10-24
Last updated
2017-02-24

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

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.

Interventions

DRUGbiphasic insulin aspart
DRUGinsulin glargine
DRUGmetformin

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Type 2 diabetes * Body mass index equal to or lesser than 35.0 kg/m2 * Currently treated with oral hypoglycaemic drug

Exclusion criteria

* Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator * Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

Design outcomes

Primary

MeasureTime frame
HbA1cMeasured at end of treatment (26 weeks)

Secondary

MeasureTime frame
safety variables
other glycemic variables
Fasting plasma glucose value

Countries

Turkey (Türkiye)

Outcome results

None listed

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