A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus (IMAGINE 5)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01582451
First received: April 19, 2012
Last updated: April 14, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:

  • Change in participants' overall blood sugar control
  • The number of night time low blood sugar episodes
  • The number of participants that reach blood sugar targets without low blood sugar episodes at night
  • The total number of low blood sugar episodes reported

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2605541
Drug: Insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 26 week endpoint in hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of total and nocturnal hypoglycemia events (adjusted by 30 days) [ Time Frame: Baseline to 26 weeks and Baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with HbA1c equal to or less than (≤) 6.5% and less than (<)7.0% [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Fasting serum glucose (FSG) (by laboratory) and fasting blood glucose (FBG) (by self monitoring) [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • 6-point self-monitored blood glucose (SMBG) [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin dose per kilogram of body weight [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Number of insulin dose adjustments to steady-state [ Time Frame: Baseline to 26 weeks ] [ Designated as safety issue: No ]
  • European Quality of Life - 5 Dimension (EuroQol-5D) score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Adult Low Blood Sugar Survey (LBSS) score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in lipid profile [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in anti-LY2605541 antibodies [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Intra-participant variability in fasting blood glucose (FBG) [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants that have total and nocturnal hypoglycemic events [ Time Frame: Baseline to 26 weeks and Baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with HbA1c < 7.0% and without nocturnal hypoglycemia [ Time Frame: 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 weeks in HbA1c [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 426
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2605541
Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted weekly based on FBG. LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Drug: LY2605541
Administered once daily at bedtime by SQ injection
Active Comparator: Insulin glargine
Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted weekly based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Drug: Insulin glargine
Administered once daily at bedtime by SQ injection

  Eligibility

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

Inclusion Criteria:

  • Have had type 2 diabetes mellitus for at least 1 year
  • Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
  • Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
  • Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
  • Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

Exclusion Criteria:

  • Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
  • Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
  • For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
  • Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
  • Have had any episodes of severe hypoglycemia within 6 months prior to screening
  • Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV
  • Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles/liter [mmol/L])
  • Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
  • Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
  • Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
  • Lipid-lowering medication: Are using or have used any of the following:

    • niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
    • lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582451

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Locations
United States, Arizona
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United States, California
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Prague, Czech Republic, 181 00
Germany
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Rhaunen, Germany, 55624
Greece
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Israel
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Puerto Rico
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Romania
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Oradea, Romania, 410169
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Russian Federation
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Novosibirsk, Russian Federation, 630091
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Saint Petersburg, Russian Federation, 192012
Spain
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Alcira, Spain, 46600
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Cadiz, Spain, 11540
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Palma De Mallorca, Spain, 07010
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Pozuelo De Alarcon, Spain, 28223
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Teruel, Spain, 44001
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01582451     History of Changes
Other Study ID Numbers: 14703, I2R-MC-BIDJ
Study First Received: April 19, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Greece: Ethics Committee
Greece: National Organization of Medicines
Israel: Ethics Commission
Israel: Ministry of Health
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on September 30, 2014