Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00592969

Enrollment

164

Registered

2008-01-14

Start date

2003-12-03

Completion date

2004-11-02

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 South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

Interventions

DRUGmetformin

DRUGbiphasic insulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Currently treated with insulin NPH or are insulin-naive * Body mass index (BMI) below 35.0 kg/m2 * HbA1c between 7.5-11.0%

Exclusion criteria

* Participation in any other clinical trial involving investigational products within the last 3 months * History of drug or alcohol dependence * Known impaired hepatic function * Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Design outcomes

Primary

Measure	Time frame
HbA1c	after 12 weeks of treatment

Secondary

Measure	Time frame
PPBG values	—
Glucose profiles	—
Hypoglycemia	—
Adverse events	—

Countries

Argentina, Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026