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A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
This study is ongoing, but not recruiting participants.
First Received: April 23, 2008   Last Updated: September 10, 2009   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00666718
  Purpose

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin Glargine
Drug: Insulin Lispro Protamine Suspension
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Insulin lispro Insulin glargine Protamine
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Insulin Lispro Protamine Suspension provides non-inferior glycemic control to insulin glargine when these basal insulins are injected once daily together with insulin lispro injected 2-3 times daily. [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c less than 7.0% and less than or equal to 6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 7-point self-monitored blood glucose profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence and rate of all self-reported hypoglycemic episodes [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent adverse events [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
  • Body weight change [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 380
Study Start Date: April 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Glargine plus Insulin Lispro (2-3 injections) plus metformin
Drug: Insulin Glargine
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
2: Experimental
Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
Drug: Insulin Lispro Protamine Suspension
patient glucose-level dependent, injection, once daily in the evening, 24 weeks

  Eligibility

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

Inclusion Criteria:

  • Diabetes Mellitus, Type 2
  • Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or TZD) with insulin for at least 3 months prior to Visit 1
  • HbA1c greater than or equal to 7.5% and less than or equal to 11.0%
  • BMI greater than or equal to 25 and less than or equal to 45 kg/m2
  • Capable and willing to follow the protocol
  • Give written consent

Exclusion Criteria:

  • Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
  • Have a history of severe hypoglycemia in the past 6 months
  • Are pregnant or may become pregnant
  • Women who are breastfeeding
  • Have significant cardiac disease
  • Have significant renal or liver disease
  • Undergoing therapy for a malignancy
  • Contraindications to the study medications
  • Have an irregular sleep/wake cycle
  • Have an serious disease or any condition considered by the investigator to be exclusionary
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666718

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Locations
Belgium
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Genk, Belgium, 3600
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Leuven, Belgium, 3000
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Willebroek, Belgium, 2830
Czech Republic
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Olomouc, Czech Republic, 77200
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Hranice I-Mesto, Czech Republic, 753 01
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Holesov, Czech Republic, 769 01
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Ostrava, Czech Republic, 709 00
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Plzen, Czech Republic, 301 66
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Prague, Czech Republic, 149 00
Germany
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Bad Mergentheim, Germany, D-97980
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Berlin, Germany, D-12351
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Damme, Germany, D-49401
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Dresden, Germany, D-01219
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Hamburg, Germany, D-22177
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Hannover, Germany, 30519
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Pirna, Germany, 01796
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Rotenburg-Fulda, Germany, D-36199
Greece
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Athens, Greece, 11526
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Larissa, Greece, 41221
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Thessaloniki, Greece, 56429
Italy
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Ancona, Italy, 60131
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Bari, Italy, 70124
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Milano, Italy, 20162
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Pistoia, Italy, 51100
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Padova, Italy, 35143
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Ravenna, Italy, 48100
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Rome, Italy, 00189
Poland
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Gorzow Wielkopolski, Poland, 66-400
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Krakow, Poland, 31-159
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Mielec, Poland, 39-300
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Lubin, Poland, 59-301
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Lodz, Poland, 93-338
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Poznan, Poland, 61-696
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Warsaw, Poland, 02-577
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Wroclaw, Poland, 503-349
Romania
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Baia Mare, Romania, 430071
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Bucharest, Romania, 020475
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Cluj-Napoca, Romania, 400006
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Sf Gheorghe, Romania
Slovakia
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Banska Bystrica, Slovakia, 97405
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Bratislava, Slovakia, 821 06
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Modra, Slovakia, 900 01
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Nitra, Slovakia, 94901
Turkey
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Bornova, Turkey, 35100
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Izmir, Turkey, 35360
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Istanbul, Turkey, 34662
United Kingdom, Scotland
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Edinburgh, Scotland, United Kingdom, EH3 9YW
United Kingdom, South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S5 7AU
United Kingdom, Warwickshire
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Rugby, Warwickshire, United Kingdom, CV22 5PX
United Kingdom, West Midlands
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West Bromwich, West Midlands, United Kingdom, B71 4HJ
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 12047, F3Z-EW-IOPJ
Study First Received: April 23, 2008
Last Updated: September 10, 2009
ClinicalTrials.gov Identifier: NCT00666718     History of Changes
Health Authority: Greece: Ethics Committee;   Greece: National Organization of Medicines;   Turkey: Ministry of Health;   Czech Republic: Ethics Committee;   Czech Republic: State Institute for Drug Control;   Belgium: Federal Agency for Medicinal Products and Health Products;   Belgium: Institutional Review Board;   Germany: Federal Institute for Drugs and Medical Devices;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United Kingdom: Research Ethics Committee;   Romania: National Medicines Agency;   Poland: Ministry of Health;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Italy: Ethics Committee;   Italy: Ministry of Health

Additional relevant MeSH terms:
Metabolic Diseases
Coagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Insulin
 Pharmacologic Actions
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glargine
Protamines
Glucose Metabolism Disorders
Heparin Antagonists

ClinicalTrials.gov processed this record on November 27, 2009



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