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Table 1 Summary of the included studies

From: Impact of Cotadutide drug on patients with type 2 diabetes mellitus: a systematic review and meta-analysis

Study ID Title Study design, country, and timing Criteria Sample size MEDI0382 treatment regimen Control group study duration
P. Ambery et al. (2018) [6] MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomized, controlled, double-blind, ascending dose and phase 2a study RCT
Germany, Dec 9, 2015, and Feb 24, 2017
• Men or women aged 18–65 years with controlled T2DM
• HbA1c levels of 6·5–8·5% at screening
• BMI between 27 kg/m2 and 40 kg/m2
• Individuals who received metformin monotherapy of 500 mg or more within three months before screening or received an adjunct to metformin were eligible after a 4-week washout period
113 patients (68 for MEDI0382, and 45 for placebo) MEDI0382 100 mcg
N = 6
MEDI0382 150 mcg
N = 6
MEDI0382 200 mcg
N = 7
MEDI0382 200 mcg
N = 25
MEDI0382 300 mcg
N = 12
MEDI0382 300 mcg
N = 12
N = 45
Participants received placebo matched to MEDI0382 dose
3 years
P. D. Ambery (2018) [15] MEDI0382, a GLP-1/glucagon receptor dual agonist, meets safety and tolerability endpoints in a single-dose, healthy-subject, randomized, Phase 1 study RCT
Germany, 26 February 2015 and 12 August 2015,
• Healthy volunteers, male or female aged 18–45 years, are chosen approximately to a population of T2DM patients minimizing the chance for concomitant medical conditions
• BMI between ≥ 22 kg.m–2 and ≤ 30 kg.m–2,
• Bodyweight ≥ 70 kg
• Individuals were required to have venous access suitable for multiple cannulations
48 patients (36 for MEDI0382, and 12 for placebo) MEDI0382 5 μg
N = 6
MEDI0382 10 μg
N = 6
MEDI0382 30 μg
N = 6
MEDI0382 100 μg
N = 6
MEDI0382 300 μg
N = 6
MEDI0382 150 μg
N = 6
N = 12
Participants received placebo matched to MEDI0382 dose
3 years
Rajaa Nahra (2021) [16] A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects with Type 2 Diabetes RCT, Bulgaria, Canada, Czechia, Germany, Mexico, Russian Federation, Slovakia, United States,
2 August 2017 and 14 June 2019
• Male and female subjects aged ≥ 18 years with T2DM
• BMI ≥ 25 kg/m2
• HbA1c range of 7.0% to 10.5%
• Individuals Treated with metformin ≥ 1500 mg/day or more for at least two months before screening or using adjuvant medication for up to 2 weeks in the two months before screening is acceptable
834 patients (612 for MEDI0382,110 for Liraglutide and 112 for placebo) MEDI0382 100 mcg
N = 100
MEDI0382 200 mcg
N = 256
MEDI0382 300 mcg
N = 256
N = 112
Participants received placebo / Metformin tablets, total daily dose of ≥ 1500 mg (unless only tolerated at a lower dose)
2 Years
NCT03745937 A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus RCT, Germany • Participants aged 18 to 74 years with T2DM
• BMI between 27 and 35 kg/m^2
• HbA1c range of 6.5% to 8.5%
• Individuals Treated with metformin monotherapy where no significant dose change (increase or decrease >  = 500 mg/day) has occurred in the three months before screening
20 patients (18 for MEDI0382 and 2 for placebo) Participants received SC dose of MEDI0382 up-titrated weekly once daily up to 8 weeks during the up-titration period and thereafter once daily in 3-week TEP N = 2
Participants received placebo matched to MEDI0382 dose
4.5 months
NCT03645421 Safety and Tolerability Study of MEDI0382 in Japanese Pre-obese or Obese Subjects With Type 2 Diabetes RCT, Japan • Individuals diagnosed with T2DM
• HbA1c range of 7.0% to 10.5%
• Individuals with drug naïve at Visit 1
• BMI within the range of 24—40 kg/m2
61 patients (45 for MEDI0382 and 16 for placebo) MEDI0382 100 mcg
N = 15
MEDI0382 200 mcg
N = 15
MEDI0382 300 mcg
N = 15
N = 16
Participants received placebo matched to MEDI0382 dose
5 months
NCT03596177 A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Subjects With Type 2 Diabetes Mellitus RCT, United Kingdom • Participants aged >  = 30 and <  = 75 years with T2DM
• Body Mass Index > 28 and <  = 40 kg/m^2
• HbA1c <  = 8.0%
• Individuals treated with metformin, with or without another adjuvant drug (increase or decrease > 50%) occurred three months before screening
• For the participant on dual therapy, a 4-week washout of the non-metformin therapy will be performed before Visit
28 patients (19for MEDI0382 and 9 for placebo) MEDI0382 titrated up to 300 μg
N = 19
N = 9
Participants received placebo matched to MEDI0382 dose
1 year and 1 month
NCT03444584 Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Subject With Type 2 Diabetes RCT, Germany, and Hungary • Male and female participants aged >  = 18 years with T2DM
• BMI between 25 kg/m^2 and 40 kg/m^2
• HA1c ranges between 7.0% and 10.0%
• Individuals treated with metformin monotherapy (MTD > 1 g) at least eight weeks or treated with stable, oral doses of dapagliflozin 10 mg and metformin (MTD > 1 g) for at least three months before screening
• For the participant on dual therapy in addition to metformin, 28 days washout period will be performed before the initial screening
49 patients (25 for MEDI0382 and 24 for placebo) MEDI0382 titrated up to 300 μg
N = 25
N = 24
Participants received placebo matched to MEDI0382 dose
7 months
Parker (2020) [17] Efficacy, safety, and mechanistic insights of cotadutide a dual receptor glucagon-like peptide-1 and glucagon agonist RCT, Germany • Patients aged ≥ 18 years had T2DM taking metformin monotherapy,
• HbA1c ranged from 6.5–8.5%
• BMI of 27–40 kg/m2
• Individuals receiving metformin monotherapy were eligible if no significant dose changes (increase or decrease ≥ 500 mg/day) occurred in the three months before screening
• Patients receiving adjuncts to metformin were allowed after a 4-week washout period
65 patients (46 for MEDI0382 and 19 for placebo) MEDI0382 titrated up to 300 μg
N = 46
N = 19
Participants received placebo matched to MEDI0382 dose
6 months
NCT03550378 A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People with Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated RCT, Germany, United Kingdom • Patients aged ≥ 18 and < 85 years at the screening with T2DM managed with any insulin or oral therapy combination where no significant dose changes of oral therapy of more than 50% have occurred in the three months before screening
• Body mass index (BMI) between 25 and 45 kg/m^2
• Haemoglobin A1c (HbA1c) range of 6.5% to 10.5%
• eGFR ≥ 30 and < 60 mL/min/1.73 m^2
• Approximately 16 participants (40%) are required to have a screening eGFR ≥ 30 and < 45 mL/min/1.73 m^2, and at least 16 participants (40%) are required to have screening eGFR ≥ 45 and < 60 mL/min/1.73 m^2
41 patients (21 for MEDI0382 and 20 for placebo) MEDI0382 titrated up to 300 μg
N = 21
N = 20
Participants received placebo matched to MEDI0382 dose
7 months
  1. RCT Randomized controlled trial, N Number, RAI Radioactive iodine therapy, MBg Megabecquerel, mCi Millicurie