The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks
| Group | Value (Percentage change) |
|---|---|
| Cotadutide 100 ug | -10.96 |
| Cotadutide 300 µg | -40.47 |
| Cotadutide 600 µg | -44.60 |
| Placebo ug | 4.60 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataAustralia, Canada, Germany, Japan, New Zealand, Poland, Spain, United Kingdom
1 trial · 1 completed · 1 with posted results
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
NCT0451584931 Aug 2020 to 8 Mar 2022
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.
Experimental
Cotadutide 100 micrograms
Cotadutide 100 micrograms administered subcutaneously
Experimental
Cotadutide 300 micrograms
Cotadutide 300 micrograms administered subcutaneously
Experimental
Cotadutide 600 micrograms
Cotadutide 600 micrograms administered subcutaneously
Placebo comparator
Placebo
Placebo administered subcutaneously
Active comparator
Semaglutide
Semaglutide 1.0 miligrams administered subcutaneously
Outcomes the sponsor listed as primary.
The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks
Time frame · Baseline to the end of 14 weeks of dosing
Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks
Time frame · Baseline to end of 26 weeks of dosing
Percentage change in UACR of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Time frame · Baseline to end of 14 weeks of dosing
Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing.
Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Time frame · Baseline to end of 26 weeks of dosing
Percentage change in body weight of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing
Time frame · Baseline to end of 14 weeks of dosing
Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing
Time frame · Baseline to end of 26 weeks of dosing
Percentage change in HbA1c of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 14 Weeks of Dosing
Time frame · Baseline to end of 14 weeks of dosing
Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks
Change in Fasting Glucose of Cotadutide at Different Dose Levels From Baseline Versus Placebo After 26 Weeks of Dosing
Time frame · Baseline to end of 26 weeks of dosing
Absolute change in fasting glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Time frame · Baseline to end of 14 weeks of dosing
Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks of dosing
Change in 10-day Average Glucose Levels of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Time frame · Baseline to end of 26 weeks of dosing
Absolute change in 10-day average glucose of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks of dosing
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks of Dosing
Time frame · Baseline to 14 weeks of dosing
Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 14 weeks
Change in Percentage Time Spent in Hyperglycaemia Over 10 Days of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks of Dosing
Time frame · Baseline to 26 weeks of dosing
Percentage change in 10-day percentage time spent in hyperglycaemia of cotadutide at different dose levels compared to placebo from baseline to end of 26 weeks
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage change) |
|---|---|
| Cotadutide 100 ug | -10.96 |
| Cotadutide 300 µg | -40.47 |
| Cotadutide 600 µg | -44.60 |
| Placebo ug | 4.60 |
| Group | Value (Percentage change) |
|---|---|
| Cotadutide 100 ug | -17.85 |
| Cotadutide 300 µg | -38.68 |
| Cotadutide 600 µg | -57.87 |
| Placebo ug | 11.79 |
| Group | Value (Percentage change) | Spread |
|---|---|---|
| Cotadutide 100 ug | -2.84 | 0.65 |
| Cotadutide 300 µg | -4.15 | 0.68 |
| Cotadutide 600 µg | -5.40 | 0.73 |
| Placebo ug | -1.61 | 0.66 |
| Group | Value (Percentage change) | Spread |
|---|---|---|
| Cotadutide 100 ug | -2.60 | 0.89 |
| Cotadutide 300 µg | -5.45 | 0.92 |
| Cotadutide 600 µg | -7.35 | 0.99 |
| Placebo ug | -2.23 | 0.90 |
| Group | Value (Percent change) | Spread |
|---|---|---|
| Cotadutide 100 µg | -0.76 | 0.12 |
| Cotadutide 300 µg | -0.82 | 0.12 |
| Cotadutide 600 µg | -0.65 | 0.12 |
| Placebo ug | -0.08 | 0.12 |
| Group | Value (Percent change) | Spread |
|---|---|---|
| Cotadutide 100 µg | -0.92 | 0.11 |
| Cotadutide 300 µg | -0.92 | 0.11 |
| Cotadutide 600 µg | -0.89 | 0.11 |
| Placebo ug | -0.25 | 0.11 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Cotadutide 100 ug | -1.35 | 0.37 |
| Cotadutide 300 µg | -1.57 | 0.35 |
| Cotadutide 600 µg | -1.69 | 0.40 |
| Placebo ug | -0.54 | 0.37 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Cotadutide 100 ug | -1.78 | 0.36 |
| Cotadutide 300 µg | -1.76 | 0.37 |
| Cotadutide 600 µg | -1.57 | 0.39 |
| Placebo ug | -0.72 | 0.37 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cotadutide 100 ugParticipants randomised to cotadutide 100 µg daily | 2 / 52 | 5 / 52 | 43 / 52 |
| Cotadutide 300 ugParticipants randomised to Cotadutide 300 ug daily | 0 / 49 | 5 / 49 | 38 / 49 |
| Cotadutide 600 ugParticipants randomised to Cotadutide 600 ug daily | 0 / 51 | 5 / 51 | 38 / 51 |
| Placebo ugParticipants randomised to placebo daily | 0 / 51 | 5 / 51 | 38 / 51 |
| Semaglutide 1 mgParticipants randomized to semaglutide 1 mg weekly | 0 / 45 | 5 / 45 | 39 / 45 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Meta-analysis (pooled) · 2025
Natale et al. 2025The Cochrane database of systematic reviewscited by 8
PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952
Indexing hint: Randomized controlled trial · 2025
Yu et al. 2025British journal of clinical pharmacologycited by 1
PMID 40344607DOI 10.1002/bcp.70093PUB-40344607
Indexing hint: Randomized controlled trial · 2024
Selvarajah et al. 2024Kidney internationalcited by 34
PMID 39218393DOI 10.1016/j.kint.2024.08.023PUB-39218393
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