Phase 3 · Exenatide

NCT00560417 trial results

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Participants
339
Status
completed
Completed
2009-12
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT00560417), updated at source Jan 13, 2011. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00560417 measured first

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])percent of glycosylated hemoglobin · Baseline, Endpoint (LOCF) up to 24 weeks · least squares mean
MeasureILPSn=170Glarginen=167
Baseline8.48(0.04)8.47(0.04)
Endpoint (LOCF) Change-1.21(0.07)-1.43(0.07)
Side effects by arm

Side effects in NCT00560417

Percent of participants affected. The most common events the registry lists.

EventILPSGlargine
Any serious event5.3%3%
Headache6.5%9%
Nausea7.6%6%
Diarrhoea6.5%7.2%
Gastroenteritis viral1.2%7.2%
Nasopharyngitis7.1%5.4%
Upper respiratory tract infection6.5%6%
Sinusitis4.1%5.4%
Nasal congestion1.8%5.4%
Arthralgia5.3%4.2%
Vomiting3.5%4.8%
Oropharyngeal pain2.4%4.2%
Abdominal discomfort3.5%2.4%
Sinus congestion3.5%1.2%
Pyrexia0.6%3%
Bronchitis0.6%3%
Pain in extremity1.8%3%
Cough2.9%3%
Urinary tract infection2.9%1.2%
Dyspepsia0.6%2.4%
Influenza2.4%1.8%
Joint sprain2.4%1.2%
Back pain1.8%2.4%
Musculoskeletal pain1.2%2.4%
Myalgia0%2.4%
Sinus headache2.4%0.6%
Secondary outcomes

What else it measured

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)percent of glycosylated hemoglobin · 24 weeks, Endpoint (LOCF) up to 24 weeks · least squares mean
MeasureILPSn=170Glarginen=167
24 weeks6.94(0.07)6.70(0.06)
Endpoint (LOCF)7.00(0.07)6.78(0.07)
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)percent of glycosylated hemoglobin · Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks · least squares mean
MeasureILPSn=170Glarginen=167
Baseline8.48(0.04)8.47(0.04)
24 Weeks Change-1.25(0.07)-1.49(0.06)
Endpoint (LOCF) Change-1.21(0.07)-1.43(0.07)
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%percent of participants · Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks · number
MeasureILPSn=170Glarginen=167
Week 12: HbA1c <7.0%46.950.7
Week 12: HbA1c <=6.5%24.828.7
Week 18: HbA1c <7.0%54.869.1
Week 18: HbA1c <=6.5%30.837.6
Week 24: HbA1c <7.0%55.463.4
Week 24: HbA1c <=6.5%29.739.9
Endpoint (LOCF): HbA1c <7.0%53.761.7
Endpoint (LOCF): HbA1c <=6.5%28.438.9
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)milligrams per deciliter (mg/dL) · Baseline, Endpoint (LOCF) up to 24 weeks · mean
MeasureILPSn=170Glarginen=167
Baseline Morning Pre-Meal175.41(39.54)180.86(38.95)
Baseline Morning Postprandial195.31(54.65)190.84(54.95)
Baseline Midday Pre-Meal165.18(43.51)166.34(47.64)
Baseline Midday Postprandial193.22(46.95)200.25(54.64)
Baseline Evening Pre-Meal173.33(44.60)175.14(43.35)
Baseline Evening Postprandial189.00(49.62)184.92(49.42)
Baseline 0300 Hours170.51(43.44)172.00(39.10)
Baseline Daily Mean 7-Point Blood Glucose180.19(36.95)180.72(38.17)
Baseline Daily Mean Pre-Meal170.60(36.06)172.66(38.60)
Baseline Daily Mean Postprandial192.37(41.48)191.27(46.11)
Endpoint Morning Pre-Meal129.63(31.58)127.01(29.08)
Endpoint Morning Postprandial152.32(44.81)137.39(36.65)
Glycemic Variability at Baseline and Endpoint (LOCF)mg/dL · Baseline, Endpoint (LOCF) up to 24 weeks · mean
MeasureILPSn=170Glarginen=167
Baseline41.15(13.69)39.02(13.52)
Endpoint36.78(16.02)30.96(13.24)
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)percentage of participants · Baseline to Endpoint (LOCF) up to 24 weeks · number
MeasureILPSn=170Glarginen=167
All Reported - Endpoint41.843.1
All Reported - Overall70.674.9
Non-Nocturnal - Endpoint30.640.1
Non-Nocturnal - Overall62.470.7
Nocturnal - Endpoint21.811.4
Nocturnal - Overall47.637.1
Severe - Endpoint00
Severe - Overall1.80
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)episodes/participant/365 days · Baseline to Endpoint (LOCF) up to 24 weeks · mean
MeasureILPSn=170Glarginen=167
All reported episodes rate - Endpoint14.51(27.75)15.29(29.73)
All reported episodes rate - Overall16.27(23.19)18.05(24.59)
Non-Nocturnal reported episodes rate - Endpoint10.40(23.46)13.20(28.01)
Non-Nocturnal reported episodes rate - Overall11.36(19.16)14.83(21.00)
Nocturnal reported episodes rate - Endpoint4.01(9.73)1.73(5.53)
Nocturnal reported episodes rate - Overall4.88(8.43)3.01(7.21)
Actual Body Weight at Baseline and Endpoint (LOCF)kilograms · Baseline, Endpoint (LOCF) up to 24 weeks · mean
MeasureILPSn=170Glarginen=167
Baseline101.57(18.67)102.62(19.58)
Endpoint101.85(18.91)103.28(19.42)
Change From Baseline in Body Weight at Endpoint (LOCF)kilograms · Baseline, Endpoint (LOCF) up to 24 weeks · mean
ILPSn=170Glarginen=167
0.27(3.38)0.66(3.93)
Total Daily Insulin Dose at Endpoint (LOCF)Units of Insulin · Endpoint (LOCF) up to 24 weeks · mean
ILPSn=168Glarginen=165
31.11(18.87)37.93(18.46)
The trial

How NCT00560417 was run

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

  • ILPS: Insulin Lispro Protamine Suspension (ILPS)
  • Glargine: Insulin Glargine
Who could join the trial

Inclusion Criteria: * Must have type 2 diabetes * Must be at least 18 years of age and less than 75 years of age * Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months * Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone * Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0% Exclusion Criteria: * Must not have used insulin on a regular basis during the past 2 years * Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months * Must not have had more than one episode of severe hypoglycemia in the past 6 months * Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease * Must not be pregnant or intend to get pregnant during the course of the study

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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