Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk A/S307 enrolled

Overview

This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

307

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes, currently treated with one or more oral hypoglycemic agent * HbA1c: At least 8.0% Exclusion Criteria: * Impaired hepatic, renal or cardiac function

Locations (11)

Novo Nordisk Investigational Site

Arkhangelsk, Russia

Novo Nordisk Investigational Site

Belgorod, Russia

Novo Nordisk Investigational Site

Kazan', Russia

Outcomes

Primary Outcomes

HbA1c

Time frame: after 16 weeks of treatment

Secondary Outcomes

Self-measured 7-point capillary plasma glucose profile

Change in body weight

Incidence of hypoglycaemic episodes and adverse events

Quality of Life

Data from ClinicalTrials.gov

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