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Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

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ClinicalTrials.gov Identifier: NCT00851903
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).

All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.

The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.

The objectives of this extension study were:

  • To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
  • To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine Drug: Sitagliptin Drug: Metformin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin
Study Start Date : June 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011


Arm Intervention/treatment
Experimental: Combination insulin glargine and sitagliptin

Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).

Sitagliptin: stable dose of 100 mg once a day administered with or without food.

Drug: Insulin Glargine
Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).
Other Name: Lantus®

Drug: Sitagliptin
Oral administration. 100mg film-coated tablets.
Other Name: Januvia®

Drug: Metformin
Patients continued with metformin as usual oral anti-diabetic treatment.




Primary Outcome Measures :
  1. HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period) [ Time Frame: study endpoint: week 12 or earlier in case of premature discontinuation ]

Secondary Outcome Measures :
  1. HbA1c: Change From Baseline to Study Endpoint [ Time Frame: baseline, study endpoint: week 12 or earlier in case of premature discontinuation ]
    Change = study endpoint - baseline

  2. Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint [ Time Frame: baseline, study endpoint: week 12 or week 8 if value not available at week 12 ]

    SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).

    Change = study endpoint - baseline.


  3. 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint [ Time Frame: baseline, study endpoint: week 12 or week 8 if value not available at week 12 ]

    7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.

    Change = study endpoint - baseline.


  4. Insulin Dose [ Time Frame: baseline, week 4, week 8, week 12 ]
    Daily dose at the face-to-face visits

  5. Number of Patients With at Least One Episode of Symptomatic Hypoglycemia [ Time Frame: During the treatment period (12 weeks) plus 7 days after last dose ]
    Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]

  6. Change in Body Weight From Baseline to Study Endpoint [ Time Frame: baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value ]
    Change = study endpoint - baseline



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Ages Eligible for Study:   35 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation,
  • HbA1c >= 7 %,
  • Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study
  • Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
  • Signed informed consent obtained prior any study procedure,
  • Willingness and ability to comply with the study protocol.

Exclusion Criteria:

  • Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
  • Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
  • Treatment with a non-permitted drug during the core study,
  • Pregnant or lactating women,
  • In-patient care,
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study),
  • Impaired renal function: serum creatinine >= 1.5 mg/dL (>= 133µmol/L) or >= 1.4 mg/dL (>=124 µmol/L) in men and women, respectively,
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure,
  • Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 x upper limit of normal range,
  • Alcohol or drug abuse within the last year,
  • Night shift worker,
  • Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
  • Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant),
  • History of pancreatitis.

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): NCT00851903


Locations
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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Colombia
Sanofi-Aventis Administrative Office
Bogota, Colombia
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
Greece
Sanofi-Aventis Administrative Office
Kallithea, Greece
Hong Kong
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
India
Sanofi-Aventis Administrative Office
Mumbai, India
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Lebanon
Sanofi-Aventis Administrative Office
Beirut, Lebanon
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00851903     History of Changes
Other Study ID Numbers: EXT_LANTU_C_02761
2008-000521-19 ( EudraCT Number )
First Posted: February 26, 2009    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: September 2012
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
Sitagliptin Phosphate
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action