A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Basal Insulin Analog; Drug: Insulin Analog Mid Mixture

Study type: Interventional

Funder types: Industry

Identifiers

NCT03018938

16507

F3Z-GH-IOQR (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.

Enrollment: 814 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have type 2 diabetes as defined by World Health Organization (WHO) criteria
• are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
• most recent HbA1c value ≥7.5% within 12 weeks of study entry
• in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
• willing to start with insulin treatment

Exclusion criteria

• have a diagnosis of type 1 diabetes
• have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
• have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
• are pregnant or breastfeeding, or intend to become pregnant during the course of the study
• are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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814 participants in 2 patient groups

Insulin Analog Mid Mixture

Experimental group

Description:

Insulin analog mid mixture given subcutaneously (SC).

Treatment:

Drug: Insulin Analog Mid Mixture

Basal Insulin Analog

Experimental group

Description:

Basal insulin analog given SC.

Treatment:

Drug: Basal Insulin Analog