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Trial record 1 of 1 for:    LANTUL07191
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Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

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ClinicalTrials.gov Identifier: NCT02836704
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

-To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs).

Secondary Objective:

  • To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.
  • To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).
  • To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).
  • To evaluate the insulin doses change.
  • To evaluate the weight change.
  • To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence.
  • To descriptively evaluate the safety profile.
  • To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration).
  • Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:
  • Age
  • Duration of diabetes
  • Baseline treatment (OAD)
  • Baseline HbA1c, FPG and PP

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE Drug: metformin Drug: acarbose Phase 4

Detailed Description:
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 892 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : April 26, 2018
Actual Study Completion Date : April 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard initial dose of insulin glargine
Dose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
Drug: INSULIN GLARGINE

Pharmaceutical form: solution

Route of administration: subcutaneous injection

Other Name: HOE901

Drug: metformin

Pharmaceutical form: table or capsule

Route of administration: oral administration


Drug: acarbose

Pharmaceutical form: table or capsule

Route of administration: oral administration


Experimental: Higher initial dose of insulin glargine
Dose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
Drug: INSULIN GLARGINE

Pharmaceutical form: solution

Route of administration: subcutaneous injection

Other Name: HOE901

Drug: metformin

Pharmaceutical form: table or capsule

Route of administration: oral administration


Drug: acarbose

Pharmaceutical form: table or capsule

Route of administration: oral administration





Primary Outcome Measures :
  1. Percentage of patients with at least one episode of hypoglycemia [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients achieving HbA1c <7% [ Time Frame: 16 weeks ]
  2. Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L) [ Time Frame: 16 weeks ]
  3. Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L) [ Time Frame: 16 weeks ]
  4. Change from baseline in HbA1c [ Time Frame: Baseline, 16 weeks ]
  5. Change from baseline in Fasting Plasma Glucose [ Time Frame: Baseline, 16 weeks ]
  6. Change from baseline in Post Prandial Glucose [ Time Frame: Baseline, 16 weeks ]
  7. Change in body weight [ Time Frame: Baseline, 16 weeks ]
  8. - Change in insulin dose [ Time Frame: Baseline, 16 weeks ]
  9. Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L]) [ Time Frame: Baseline, 16 weeks ]
  10. Number of nocturnal hypoglycemic events [ Time Frame: Baseline, 16 weeks ]
  11. Number of severe hypoglycemic events [ Time Frame: Baseline, 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Age ≥ 18 and ≤ 70 years.
  • Type 2 diabetes patients with diabetes diagnosis at least 2 years.
  • Continuous treatment with stable doses of 2-3 OADs, for more than three months prior to randomization, among which metformin ≥1.5 g/day or at maximum tolerated dose
  • HbA1c >7.5% and ≤11%.
  • FPG >9 mmol/L.
  • BMI ≥25 and ≤40 kg/m^2.
  • Ability and willingness to perform self-monitoring of blood glucose using the Sponsor-provided glucose meter and to complete the patient diary.
  • Willingness and ability to comply with the study protocol.
  • Signed informed consent obtained prior any study procedure.

Exclusion criteria:

  • Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
  • History of hypoglycemia unawareness.
  • Unexplained hypoglycemia in the past 6 months.
  • Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
  • Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma).
  • History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the previous 12 months.
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination or disease history record, in the 2 years prior to study entry.
  • Impaired renal function defined as, but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (>2 g/day).
  • Active liver disease (alanine transaminase [ALT] greater than two times the upper limit of the reference range, as defined by the local laboratory).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836704


Locations
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China
China, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02836704     History of Changes
Other Study ID Numbers: LANTUL07191
U1111-1172-2903 ( Other Identifier: UTN )
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action