Clinical trial NCT03861052: A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes
Official title: A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 636
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.


Eligibility criteria: Inclusion Criteria:

Participant must:

* Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.
* Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:

  * for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.
  * for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.
* Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
* Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.

Exclusion Criteria:

Participant must not:

* Have type 1 diabetes mellitus.
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Percentage of Participants With HbA1c of <7.0%
timeFrame: Week 52
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 52
measure: Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline
timeFrame: Week 52
measure: Change From Baseline in Fasting Insulin
timeFrame: Baseline, Week 52
measure: Change From Baseline in Fasting C-Peptide
timeFrame: Baseline, Week 52
measure: Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)
timeFrame: Baseline, Week 52
measure: Change From Baseline in HOMA-2S (Insluin)
timeFrame: Baseline, Week 52
measure: Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia
timeFrame: Baseline through Week 52
measure: Number of Participants With Anti-Tirzepatide Antibodies
timeFrame: Baseline through Week 52
Other outcomes:
Locations:
city: Chiba Mihama-ku
country: Japan
facility: Medical corporation THY Tokuyama Clinic
state: Chiba
city: Chiba-shi
country: Japan
facility: Akaicho Clinic
state: Chiba
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Yuri Ono Clinic
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Watanabe Naika Clinic
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hayashi Clinic
state: Hyogo
city: Naka
country: Japan
facility: Naka Memorial Clinic
state: Ibaraki
city: Chigasaki-sh
country: Japan
facility: Hayashi Diabetes Internal Medicine Clinic
state: Kanagawa
city: Ebina
country: Japan
facility: Matoba Diabetes Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Takai Naika Clinic
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: H.E.C. Science Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Toyonaka
country: Japan
facility: Senrichuo Ekimae Clinic
state: Osaka
city: Kawagoe
country: Japan
facility: Asano Clinic
state: Saitama
city: Kawaguchi
country: Japan
facility: Kawaguchi General Hospital
state: Saitama
city: Shimotsuke
country: Japan
facility: Wakakusa Clinic
state: Tochigi
city: Adachi-ku
country: Japan
facility: Seiwa Clinic
state: Tokyo
city: Chiyodaku
country: Japan
facility: Meiwa Hospital
state: Tokyo
city: Chiyoda
country: Japan
facility: HDC Atlas Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Asahi Life Foundation Adult Disease Research Center
state: Tokyo
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo aSBo Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: IHL Shinagawa East One Medical Clinic
state: Tokyo
city: Ootaku
country: Japan
facility: Sato Medical Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tomonaga Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Shinjuku Research Park Clinic
state: Tokyo
city: Suginami
country: Japan
facility: Shinei Clinic
state: Tokyo
city: Toshima-ku
country: Japan
facility: Ikebukuro Metropolitan Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Futata Tetsuhiro Clinic
city: Hiroshima
country: Japan
facility: JR Hiroshima Hospital
city: Kumamoto
country: Japan
facility: Yoshimura Clinic
city: Kyoto
country: Japan
facility: Keiseikai Kajiyama Clinic
city: Oita
country: Japan
facility: Abe Clinic
city: Okayama
country: Japan
facility: OKAYAMA Medical Center
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Osaka
country: Japan
facility: Kitada Clinic
city: Osaka
country: Japan
facility: Nanko Clinic
city: Shizuoka
country: Japan
facility: Suruga Clinic
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Inagaki N, Takeuchi M, Oura T, Imaoka T, Seino Y. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):623-633. doi: 10.1016/S2213-8587(22)00188-7. Epub 2022 Jul 30.
citation: Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.