Phase 3 · Dulaglutide

NCT01191268 trial results

The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin), Baseline, 26 weeks. 1.5 mg LY2189265: -1.64; 0.75 mg LY2189265: -1.59; Insulin Glargine: -1.41.

Participants: 884
Status: completed
Completed: 2012-09
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01191268), updated at source Oct 8, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01191268 measured first

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)percentage of glycosylated hemoglobin · Baseline, 26 weeks · least squares mean

1.5 mg LY2189265n=273	0.75 mg LY2189265n=275	Insulin Glarginen=276
-1.64(0.07)	-1.59(0.07)	-1.41(0.07)

Side effects by arm

Side effects in NCT01191268

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

Event	1.5 mg LY2189265	0.75 mg LY2189265	Insulin Glargine
Any serious event	9.2%	15.7%	17.9%
Nausea	25.8%	17.7%	3%
Diarrhea	14.9%	11.6%	5.1%
Vomiting	11.9%	10.6%	1.7%
Nasopharyngitis	7.5%	0.3%	11.1%
Common cold	6.4%	9.6%	8.8%
Headache	5.4%	6.8%	5.7%
Oedema peripheral	2.4%	5.8%	3%
Arthralgia	0.3%	1.4%	5.4%
Urinary tract infection	4.1%	4.8%	3.7%
Abdominal pain upper	4.4%	0.7%	0.7%
Heartburn	4.4%	1.4%	0.3%
Bronchitis	2.4%	3.1%	4.4%
Pain in extremity	3.1%	4.4%	2.7%
Constipation	4.1%	2%	1.7%
Gastrooesophageal reflux disease	0.3%	3.8%	1.7%
Dyspepsia	3.7%	1%	0.3%
Fatigue	3.7%	2.4%	1.7%
Upper respiratory tract infection	1%	0.7%	3.7%
Anorexia	3.7%	1.7%	0%
Decreased appetite	3.4%	2.7%	0%
Dyslipidaemia	3.4%	1.7%	1.7%
Dyslipidemia	3.4%	1.7%	1.7%
Flu syndrome	1.4%	3.1%	0.7%
Musculoskeletal pain	3.1%	0.3%	3%
Shoulder pain	3.1%	1.4%	3%

Secondary outcomes

What else it measured

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)percentage of glycosylated hemoglobin · Baseline, 52 weeks · least squares mean

1.5 mg LY2189265n=273	0.75 mg LY2189265n=275	Insulin Glarginen=276
-1.48(0.08)	-1.42(0.08)	-1.23(0.08)

Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52percentage of participants · 26 weeks and 52 weeks · number

Measure	1.5 mg LY2189265n=275	0.75 mg LY2189265n=277	Insulin Glarginen=280
HbA1c less than 7.0%, 26 weeks	67.6	69.0	56.8
HbA1c less than 7.0%, 52 weeks	58.5	56.3	49.3
HbA1c less than or equal to 6.5%, 26 weeks	48.0	43.0	37.5
HbA1c less than or equal to 6.5%, 52 weeks	36.7	34.7	30.4

Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemiapercentage of participants · Baseline, 26 weeks, and 52 weeks · number

Measure	1.5 mg LY2189265n=275	0.75 mg LY2189265n=277	Insulin Glarginen=280
26 weeks	53.8	54.5	28.2
52 weeks	44.0	44.0	26.8

Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profilesmillimoles per liter (mmol/L)] · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=295	0.75 mg LY2189265n=293	Insulin Glarginen=296
Pre-morning meal, 26 weeks (n=228, 231, 232)	-0.36(0.14)	-0.06(0.14)	-2.01(0.14)
Post-morning meal, 26 weeks (n=220, 227, 229)	-3.70(0.19)	-3.29(0.19)	-4.03(0.18)
Pre-midday meal, 26 weeks (n=227, 231, 233)	-2.80(0.16)	-2.38(0.16)	-2.65(0.16)
Post-midday meal, 26 weeks (n=219, 227, 228)	-4.51(0.17)	-4.53(0.17)	-3.70(0.17)
Pre-evening meal, 26 weeks (n=226, 231, 232)	-3.24(0.16)	-3.06(0.16)	-2.74(0.16)
Post-evening meal, 26 weeks (n=220, 228, 227)	-4.61(0.17)	-4.54(0.17)	-3.90(0.17)
Bedtime, 26 weeks (n=220, 221, 226)	-4.00(0.17)	-3.89(0.17)	-3.40(0.17)
After bedtime, 26 weeks (n=208, 216, 208)	-1.48(0.15)	-1.50(0.15)	-1.96(0.15)
Daily Mean, 26 weeks (n=202, 206, 199)	-3.17(0.12)	-2.97(0.12)	-3.10(0.12)
Pre-morning meal, 52 weeks (n=207, 213, 218)	0.03(0.16)	0.05(0.15)	-2.02(0.15)
Post-morning meal, 52 weeks (n=200, 211, 211)	-3.38(0.19)	-3.23(0.19)	-3.76(0.19)
Pre-midday meal, 52 weeks (n=207, 213, 218)	-2.53(0.14)	-2.52(0.14)	-2.63(0.14)

Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucosemillimoles per liter (mmol/L) · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=295	0.75 mg LY2189265n=292	Insulin Glarginen=294
26 weeks (n=253, 256, 255)	-0.27(0.20)	0.22(0.20)	-1.58(0.20)
52 weeks (n=237, 238, 246)	0.08(0.22)	0.41(0.22)	-1.01(0.22)

Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)units · Baseline and 26 weeks and 52 weeks · mean

Measure	1.5 mg LY2189265n=295	0.75 mg LY2189265n=293	Insulin Glarginen=296
TDI, Baseline	55.20(32.17)	59.11(38.12)	53.93(30.67)
TDI, 26 weeks (n=244, 251, 254)	93.24(78.02)	96.69(62.13)	132.00(79.01)
TDI, 52 weeks (n=224, 227, 238)	88.15(62.95)	95.00(67.62)	133.19(80.75)
Insulin Lispro, 26 weeks (n=244, 251, 254)	93.24(78.02)	96.69(62.13)	67.79(44.59)
Insulin Lispro, 52 weeks (n=224, 227, 238)	88.15(62.95)	95.00(67.62)	69.12(49.07)
Insulin Glargine, 26 weeks (n=244, 251, 254)	NA(NA)	NA(NA)	64.48(40.23)
Insulin Glargine, 52 weeks (n=224, 227, 238)	NA(NA)	NA(NA)	64.07(38.60)

Change From Baseline to 26 and 52 Weeks in Body Weightkilograms (kg) · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=286	0.75 mg LY2189265n=289	Insulin Glarginen=294
26 weeks	-0.87(0.27)	0.18(0.27)	2.33(0.27)
52 weeks	-0.35(0.34)	0.86(0.33)	2.89(0.33)

Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dosekilograms (kg) · Baseline and 52 weeks and 4 weeks after last dose · mean

Measure	1.5 mg LY2189265n=295	0.75 mg LY2189265n=293	Insulin Glarginen=296
Baseline	91.00(18.24)	91.69(18.03)	90.75(18.87)
52 weeks (n=290, 290, 295)	91.58(19.06)	93.21(19.23)	94.14(19.72)
4 weeks after last dose (n=259, 260, 253)	91.69(18.60)	93.14(19.20)	94.27(20.13)

Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)kilograms per meter squared (kg/m^2) · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=295	0.75 mg LY2189265n=293	Insulin Glarginen=296
26 weeks (n=248, 251, 250)	-0.20(0.09)	0.21(0.09)	1.01(0.09)
52 weeks (n=225, 224, 232)	0.09(0.11)	0.57(0.11)	1.33(0.11)
4 weeks after last dose	NA(NA)	NA(NA)	NA(NA)

Change From Baseline to 26 and 52 Weeks in the EQ-5Dunits on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=295	0.75 mg LY2189265n=293	Insulin Glarginen=296
EQ-5D UK, 26 weeks (n=272, 271, 274)	-0.03(0.01)	-0.03(0.01)	-0.03(0.01)
EQ-5D UK, 52 weeks (n=274, 274, 281)	-0.04(0.01)	-0.04(0.01)	-0.03(0.01)
VAS, 26 weeks (n=278, 275, 275)	-1.69(1.00)	-2.30(1.00)	-0.60(1.00)
VAS, 52 weeks (n=279, 278, 282)	-0.46(1.01)	-2.54(1.02)	-0.18(1.01)

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)units on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=293	0.75 mg LY2189265n=290	Insulin Glarginen=294
26 weeks (n=274, 270, 270)	-0.50(0.30)	-0.60(0.31)	-0.93(0.31)
52 weeks (n=277, 275, 279)	-0.50(0.33)	-1.05(0.33)	-1.28(0.33)

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)units on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean

Measure	1.5 mg LY2189265n=293	0.75 mg LY2189265n=291	Insulin Glarginen=295
26 weeks (n=277, 274, 274)	0.60(0.17)	0.34(0.17)	0.18(0.17)
52 weeks (n=278, 277, 281)	0.86(0.16)	0.22(0.16)	0.06(0.16)

The trial

How NCT01191268 was run

The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.

1.5 mg LY2189265: LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
0.75 mg LY2189265: LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
Insulin Glargine: Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Who could join the trial

Inclusion Criteria: * Type 2 diabetes * Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications * Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11% * Willing to inject subcutaneous medication * Willing to monitor blood glucose levels and adjust insulin dose * Willing to maintain a study diary * Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2) * Stable weight for 3 months prior to screening * Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug Exclusion Criteria: * Type 1 Diabetes * Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening * 1 or more episodes of ketoacidosis within 6 months prior to screening * Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening * Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening * Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled * History of heart failure, New York Heart Classification III or IV within 2 months prior to screening * Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility * Acute or chronic hepatitis or pancreatitis * Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia * Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening * Organ transplant except cornea * Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis * History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years * Known drug or alcohol abuse * Have enrolled in another clinical trial within the last 30 days * Have previously signed an informed consent or participated in a LY2189265 study

Published papers

Papers from NCT01191268

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

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