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 | Completed Phase 4

• 2 other identifiers: GLARGL07921U1111-1183-8755
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in HbA1c

  Baseline, Week 24

Secondary Outcomes (7)

• Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL

  At Weeks 12 and 24

• Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)

  At Weeks 12 and 24

• Duration to reach target pre-breakfast SMBG

  Baseline, Week 24

• Mean change from baseline in HbA1c

  Baseline, Week 12

• Mean change from baseline in SMBG

  Baseline, Weeks 12, and 24

Study Arms (1)

Insulin glargine (U300)

EXPERIMENTAL

Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.

Drug: INSULIN GLARGINE (U300); Drug: metformin; Drug: sulfonylurea; Drug: meglitinides; Drug: thiazolidinediones; Drug: alpha-glucosidase inhibitors; Drug: GLP1 Receptor Agonist; Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors; Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors

Interventions

INSULIN GLARGINE (U300) DRUG

Pharmaceutical form: pen for injection Route of administration: subcutaneous

Also known as: HOE901

Insulin glargine (U300)

metformin DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

sulfonylurea DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

meglitinides DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

thiazolidinediones DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

alpha-glucosidase inhibitors DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

GLP1 Receptor Agonist DRUG

Pharmaceutical form: pen for injection Route of administration: subcutaneous

Insulin glargine (U300)

Dipeptidyl peptidase-IV (DPP-IV) inhibitors DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

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

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine (U300)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with type 2 diabetes mellitus (≥18 years of age).
• Type 2 diabetes mellitus diagnosis ≥1 year.
• Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
• Stable antidiabetic treatment for at least 3 months.
• Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose \[SMBG\]).
• Signed informed consent obtained.

You may not qualify if:

• Age \<18 years old.
• Type 1 diabetes mellitus.
• Having secondary type 2 diabetes mellitus.
• Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
• History of hypoglycemia unawareness.
• Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
• Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
• Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
• Pregnant or lactating women.
• Participation in another clinical trial.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Metformin; Sulfonylurea Compounds; meglitinide; Thiazolidinediones; Glycoside Hydrolase Inhibitors; Dipeptidyl Peptidase 4; Sodium-Glucose Transporter 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers; Sodium-Glucose Transport Proteins; Symporters; Ion Pumps; Membrane Transport Proteins; Carrier Proteins; Proteins; Monosaccharide Transport Proteins; Solute Carrier Proteins; Membrane Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 3, 2016
• Study Start: November 30, 2016
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

TU (1)