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
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: lixisenatide (AVE0010)
Drug: placebo
Drug: insulin glargine (HOE901)
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in glycated hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 446
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: lixisenatide (AVE0010)
solution for subcutaneous injection
Drug: insulin glargine (HOE901)
solution for subcutaneous injection
Drug: metformin
continued at a stable dose throughout the study
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)
Drug: placebo
solution for subcutaneous injection
Drug: insulin glargine (HOE901)
solution for subcutaneous injection
Drug: metformin
continued at a stable dose throughout the study

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975286

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Locations
United States, Arizona
Sanofi-Aventis Investigational Site Number 840223
Mesa, Arizona, United States, 85206
United States, Arkansas
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Hot Springs, Arkansas, United States, 71913
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Little Rock, Arkansas, United States, 72205
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France
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Le Creusot, France, 71200
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Germany
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Dresden, Germany, 01307
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Hannover, Germany, 30159
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Hungary
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Israel
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Tel Hashomer, Israel, 52621
Italy
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Malaysia
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Netherlands
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Amsterdam, Netherlands, 1066 EC
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Eindhoven, Netherlands, 5631 BM
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Groningen, Netherlands, 9728 NT
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Waalwijk, Netherlands, 5141 BM
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Poland
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Plock, Poland, 09-400
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Sopot, Poland, 81-756
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Szczecin, Poland, 70-506
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Ponce, Puerto Rico, 00717
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Brasov, Romania, 500326
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Bucharest, Romania, 020725
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Deva, Romania, 330084
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Iasi, Romania, 700515
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Oradea, Romania, 410598
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Targu Mures, Romania, 540061
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Timisoara, Romania, 300593
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Timisoara, Romania, 300456
Russian Federation
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Saratov, Russian Federation, 410030
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St. Petersburg, Russian Federation, 194358
South Africa
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Cape Town, South Africa, 7708
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Durban, South Africa, 4092
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Pretoria, South Africa
Sweden
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Göteborg, Sweden, 413 45
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Härnösand, Sweden, 871 82
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Luleå, Sweden, 972 33
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Malmö, Sweden, 211 52
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Stockholm, Sweden, 111 57
Taiwan
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Changhua, Taiwan, 500
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Taichung, Taiwan, 433
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Taichung R.O.C., Taiwan, 407
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Tainan Hsien, Taiwan, 710
Ukraine
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Chernivtsi, Ukraine, 58022
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Kiev, Ukraine, 2091
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Kyiv, Ukraine
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Kyiv, Ukraine, 31156
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Vinnytsya, Ukraine, 21010
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Study Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00975286     History of Changes
Other Study ID Numbers: EFC10781, EudraCT : 2008-007335-40
Study First Received: September 10, 2009
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014