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A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

NCT02954692 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-01-14

No results posted yet for this study

Summary

Primary Objective:

To assess the mean change in HbA1c (glycated haemoglobin).

Secondary Objectives:

To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:

* Targeted HbA1c;
* Targeted fasting self- monitoring blood glucose (SMBG);
* Hypoglycemic events;
* Adverse events;
* Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
* Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.

Conditions

Interventions

DRUG

INSULIN GLARGINE (U300)

Pharmaceutical form: pen for injection Route of administration: subcutaneous

DRUG

metformin

Pharmaceutical form: tablet Route of administration: oral

DRUG

sulfonylurea

Pharmaceutical form: tablet Route of administration: oral

DRUG

meglitinides

Pharmaceutical form: tablet Route of administration: oral

DRUG

thiazolidinediones

Pharmaceutical form: tablet Route of administration: oral

DRUG

alpha-glucosidase inhibitors

Pharmaceutical form: tablet Route of administration: oral

DRUG

GLP1 Receptor Agonist

Pharmaceutical form: pen for injection Route of administration: subcutaneous

DRUG

Dipeptidyl peptidase-IV (DPP-IV) inhibitors

Pharmaceutical form: tablet Route of administration: oral

DRUG

Sodium-glucose transport-2 (SGLT-2) inhibitors

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-12-22
Completion
2017-12-22

Countries

  • Turkey (Türkiye)

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954692 on ClinicalTrials.gov