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Completed

NCT Number: NCT00851903

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).

Other names: Lantus®

Sitagliptin

Drug

Oral administration. 100mg film-coated tablets.

Other names: Januvia®

metformin

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2009
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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