Evidence mapPaperPMID 33622669Full record

Trial reportDiabetes care2021

The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes.

Klara R Klein, Jennifer L R Freeman, Imogene Dunn, Chris Dvergsten, M Sue Kirkman, John B Buse, Carmen Valcarce, SimpliciT1 research group

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Klara R KleinDivision of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC klara_klein@med.unc.edu.ORCID 0000-0002-5894-9054
Jennifer L R FreemanvTv Therapeutics LLC, High Point, NC.
Imogene DunnvTv Therapeutics LLC, High Point, NC.
Chris DvergstenvTv Therapeutics LLC, High Point, NC.
M Sue KirkmanDivision of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.ORCID 0000-0002-5194-9609
John B BuseDivision of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.
Carmen Valcarce
SimpliciT1 research group
University of North Carolina at Chapel Hill · USvTv Therapeutics (United States) · US

Funding

Pilot & Feasibility ProgramP30DK124723 · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2025 to 2025
$1.6M
NCATS NIH HHS UL1 TR002489NIDDK NIH HHS P30 DK124723
6 · The paper itself

Abstract

objectiveDespite advances in exogenous insulin therapy, many patients with type 1 diabetes do not achieve acceptable glycemic control and remain at risk for ketosis and insulin-induced hypoglycemia. We conducted a randomized controlled trial to determine whether TTP399, a novel hepatoselective glucokinase activator, improved glycemic control in people with type 1 diabetes without increasing hypoglycemia or ketosis. RESEARCH DESIGN AND

methodsSimpliciT1 was a phase 1b/2 adaptive study. Phase 2 activities were conducted in two parts. Part 1 randomly assigned 20 participants using continuous glucose monitors and continuous subcutaneous insulin infusion (CSII). Part 2 randomly assigned 85 participants receiving multiple daily injections of insulin or CSII. In both parts 1 and 2, participants were randomly assigned to 800 mg TTP399 or matched placebo (fully blinded) and treated for 12 weeks. The primary end point was change in HbA

resultsThe difference in change in HbA

conclusionsTTP399 lowers HbA

Indexed as

Diabetes Mellitus, Type 1GlucokinaseDouble-Blind MethodGlycated HemoglobinHumansHypoglycemic AgentsInsulinOrganic ChemicalsTreatment OutcomeGlucokinaseGlycated HemoglobinHypoglycemic AgentsInsulinOrganic ChemicalsTTP399

Identifiers

PMID33622669
PMCPMC7985421
OpenAlexW3131165749

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.