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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

NCTNCT01514149 (opens ClinicalTrials.gov in a new tab)Other idDM200-103
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in the eligibility rules.
  • Names Exenatide (exendin-4), does not test it. It appears in the conditions.

Overview

Status
Terminated
Phase
Phase 2
Enrollment
73 participants (actual)
Sponsor
ConjuChem · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

United States, Canada

Start
Sept 2011
Primary completion
May 2012
Completion
Mar 2013
First posted
20 Jan 2012 (estimated)
Last update posted
19 Jul 2017
Conditions
Type 2 Diabetes Mellitus (T2DM)

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph 2

    Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

    NCT01514149

    Sept 2011 to Mar 2013

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.

Interventions

  • CJC-1134-PC InjectionDrug
  • Weekly placebo for CJC-1134-PC InjectionDrug

Arms5

  • Experimental

    Arm 1 - Weekly CJC-1134-PC

  • Experimental

    Arm 2 - Weekly CJC-1134-PC

  • Experimental

    Arm 3 - Weekly CJC-1134-PC

  • Experimental

    Arm 4 - Weekly CJC-1134-PC

  • Placebo comparator

    Arm 5 - Weekly Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18

    Time frame · CFB to Week 18

Secondary outcomes(2)

  1. Fasting Body Weight CFB to Week 18

    Time frame · CFB to Week 18

  2. Time to Hyperglycemia Rescue

    Time frame · 18 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· CFB to Week 18

Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18

GroupValue (Percent (%))Spread
Arm 1 - Weekly CJC-1134-PC-0.560.597
Arm 2 - Weekly CJC-1134-PC-0.560.627
Arm 3 - Weekly CJC-1134-PC-0.950.746
Arm 4 - Weekly CJC-1134-PC-0.950.828
Arm 5 - Weekly Placebo-0.130.811
Secondary and other outcome results(2)
Secondary outcomeMean· CFB to Week 18

Fasting Body Weight CFB to Week 18

GroupValue (kg)Spread
Arm 1 - Weekly CJC-1134-PC-1.911.624
Arm 2 - Weekly CJC-1134-PC-0.144.122
Arm 3 - Weekly CJC-1134-PC-1.372.182
Arm 4 - Weekly CJC-1134-PC-0.921.999
Arm 5 - Weekly Placebo-1.854.083
Secondary outcomeMean· 18 weeks

Time to Hyperglycemia Rescue

GroupValue (days)Spread
Arm 1 - Weekly CJC-1134-PCNANA
Arm 2 - Weekly CJC-1134-PC47.053.74
Arm 3 - Weekly CJC-1134-PCNANA
Arm 4 - Weekly CJC-1134-PCNANA
Arm 5 - Weekly Placebo57.0NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Arm 1 - Weekly CJC-1134-PCCJC-1134-PC, 1.5 mg. weekly subcutaneous injection0 / 120 / 123 / 12
Arm 2 - Weekly CJC-1134-PCCJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection0 / 150 / 1511 / 15
Arm 3 - Weekly CJC-1134-PCCJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection0 / 130 / 138 / 13
Arm 4 - Weekly CJC-1134-PCCJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection0 / 130 / 138 / 13
Arm 5 - Weekly PlaceboWeekly placebo for CJC-1134-PC administered weekly by subcutaneous injection0 / 140 / 145 / 14

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Men or women 18 to 70 years of age, inclusive * Body mass index of 27 to 45 kg/m2 * Diagnosed with T2DM for at least 6 months before screening * Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening * FPG ≤240 mg/dL at screening * HbA1c ≥7.0% and ≤11% at screening * A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval Exclusion Criteria: * Pregnant or breastfeeding women * Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening * Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening * Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening * Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy * Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening

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