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Trial · NCT04816890

A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)

NCT04816890, Phase 2, Completed, Adocia

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM). Trials, record NCT04816890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04816890

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
NCT number
NCT04816890
Status
Completed
Phases
Phase 2
Enrollment
80 participants, actual
Lead sponsor
Adocia
Conditions
Type 1 Diabetes Mellitus
Interventions
M1 Pram P037, Insulin lispro
First posted
2021-03-25
Last updated
2022-06-24

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryBody weight change from baseline to week 16 of treatmentFrom week 0 to week 16Change in body weight after 16 weeks of treatment
SecondaryTIR [70-180] mg/dL.From week 0 to week 16Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
Secondary%TIR [70-180] mg/dL.From week 0 to week 16Percentage of Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
SecondaryTIR [70-140] mg/dL.From week 0 to week 16Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
Secondary%TIR [70-140] mg/dL.From week 0 to week 16Percentage of Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
SecondaryMeanG_24hFrom week 0 to week 16Average glucose over 24h change from baseline to week 16 of treatment
SecondaryCVG_24hFrom week 0 to week 16Coefficient Of Variation of glucose over 24h change from baseline to week 16 of treatment.
SecondaryDistG_24hFrom week 0 to week 16Distance travelled over 24h change from baseline to week 16 of treatment
SecondarySDG_24hFrom week 0 to week 16Standard Deviation of all glucose values over 24h change from baseline to week 16 of treatment
SecondaryHbA1cFrom week 0 to week 16HbA1c change from baseline to week 16 of treatment

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
39109464DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04816890

GET https://conductscience.org/api/trials/v1/NCT04816890/registered