24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine (GetGoal Duo1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00975286
First received: September 10, 2009
Last updated: May 7, 2012
Last verified: May 2012

September 10, 2009
May 7, 2012
October 2009
August 2011   (final data collection date for primary outcome measure)
Change from baseline in glycated hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in glycated hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00975286 on ClinicalTrials.gov Archive Site
  • Percentage of patients with HbA1c <7 % [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c ≤6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in 2-hour postprandial plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in plasma glucose excursions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in 7-point Self Monitored Plasma Glucose (SMPG) profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in insulin glargine dose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients requiring rescue therapy during the double-blind period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in treatment satisfaction score (DTSQ questionnaire) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c <7 %, < or = 6.5 % [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in postprandial plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in 7-point Self Monitored Plasma Glucose (SMPG) profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in insulin glargine dose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients requiring rescue therapy during the double-blind period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in treatment satisfaction score (DTSQ questionnaire) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

The primary objective of this study is to assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to insulin glargine and metformin over a period of 24 weeks.

The secondary objectives are :

  • To assess the effects of lixisenatide on the percentage of patients reaching HbA1c <7 % and < or = 6.5 %, on plasma glucose (fasting, post-prandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses.
  • To evaluate lixisenatide safety and tolerability as add on treatment to insulin glargine and metformin.
  • To assess the impact of lixisenatide on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

The study will comprise 3 periods:

  • An up-to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.
  • At the end of the run-in phase, patients whose HbA1c (centralized assay) is > or = 7% and < or = 9% and whose mean fasting SMPG calculated from the self measurements for the 7 days prior to visit 12 (week -1) is less than or equal to 140 mg/dl (7.8 mmol/l), will enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/-TZDs).
  • A 3 day-safety follow up period.

Maximum duration of 39 weeks ± 7 days

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: lixisenatide (AVE0010)
    solution for subcutaneous injection
  • Drug: placebo
    solution for subcutaneous injection
  • Drug: insulin glargine (HOE901)
    solution for subcutaneous injection
  • Drug: metformin
    continued at a stable dose throughout the study
  • Experimental: Lixisenatide
    24-week treatment with lixisenatide once daily on top of insulin glargine (both injected in the morning within 1 hour prior to breakfast) and metformin (at least 1.5g/day)
    Interventions:
    • Drug: lixisenatide (AVE0010)
    • Drug: insulin glargine (HOE901)
    • Drug: metformin
  • Placebo Comparator: Placebo
    24-week treatment with placebo once daily on top of insulin glargine (both injected in the morning within 1 hour prior to breakfast) and metformin (at least 1.5g/day)
    Interventions:
    • Drug: placebo
    • Drug: insulin glargine (HOE901)
    • Drug: metformin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

At screening:

  • Patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose > or = 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose > or = 11.1 mmol/L (200 mg/dL), diagnosed at least 1 year before the screening visit
  • For at least 3 months: treatment with a stable dose of metformin > or = 1.5 g/day or combination of stable doses of metformin > or = 1.5 g/day with sulfonylureas (SUs) (to be stopped at the run-in visit (V2)) and/or Thiazolidinediones (TZDs)
  • Glycated hemoglobin (HbA1c) > or = 7.0 and < or = 10%

At the end of the run in phase and before randomization:

  • HbA1c > or = 7.0 and < or = 9%
  • Mean fasting Self Monitored Plasma Glucose (SMPG) calculated from the self measurements for the 7 days prior to visit 12 (week -1) is less than or equal to 140 mg/dll (7.8 mmol/l)

Exclusion criteria:

At screening:

  • Pregnancy or lactation
  • Women of childbearing potential with no effective contraceptive method.
  • Type 1 diabetes mellitus
  • Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit.
  • Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea and thiazolidinediones within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit.
  • History of hypoglycemia unawareness.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
  • Known history of drug or alcohol abuse within 6 months prior to the time of screening
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening
  • Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
  • History of hypersensitivity to insulin glargine or to any of the excipients
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e worsening) and not controlled (i.e prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
  • Any previous treatment with lixisenatide (e.g. participation in a previous study with lixisenatide)
  • Allergic reaction to any GLP-1 receptor agonist in the past (e.g. exenatide, liraglutide) or to metacresol

Additional exclusion criteria during or at the end of the run-in phase before randomization :

  • Informed consent withdrawal (patient who is not willing to continue or fails to return)
  • Mean fasting SMPG calculated from the self-measurements for the 7 days prior to visit 12 (week -1) is > 140 mg/dl (7.8 mmol/l)
  • HbA1c measured at visit 12 (week -1) is < 7% or > 9 %,
  • Amylase and/or lipase > 3 times the upper limit of the normal laboratory range at visit 12 (week -1)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Malaysia,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Sweden,   Taiwan,   Ukraine
 
NCT00975286
EFC10781, EudraCT : 2008-007335-40
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Study Operations Sanofi
Sanofi
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP