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

• Sponsor: ConjuChem (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01514149
• Collaborator: (none)
• Enrollment: 73
• Locations: 22
• Arms: 5
• Duration (Months): 18
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus (T2DM)	Drug: CJC-1134-PC Injection; Drug: Weekly placebo for CJC-1134-PC Injection	Phase 2

Detailed Description

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 (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.

Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.

CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 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
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 - Weekly CJC-1134-PC	Drug: CJC-1134-PC Injection; CJC-1134-PC administered weekly by subcutaneous injection; Other Names: metformin
Experimental: Arm 2 - Weekly CJC-1134-PC	Drug: CJC-1134-PC Injection; CJC-1134-PC administered weekly by subcutaneous injection; Other Names: metformin
Experimental: Arm 3 - Weekly CJC-1134-PC	Drug: CJC-1134-PC Injection; CJC-1134-PC administered weekly by subcutaneous injection; Other Names: metformin
Experimental: Arm 4 - Weekly CJC-1134-PC	Drug: CJC-1134-PC Injection; CJC-1134-PC administered weekly by subcutaneous injection; Other Names: metformin
Placebo Comparator: Arm 5 - Weekly Placebo	Drug: Weekly placebo for CJC-1134-PC Injection; Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection; Other Names: metformin

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Fasting Body Weight CFB to Week 18 [CFB to Week 18]

2. Time to Hyperglycemia Rescue [18 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Phoenix	Arizona	United States	85018
2	Research Site	Inglewood	California	United States	90301
3	Research Site	Tarzana	California	United States	91356
4	Research Site	Ventura	California	United States	93003
5	Research Site	Wellington	Florida	United States	33414
6	Research Site	Idaho Falls	Idaho	United States	83404
7	Research Site	Lexington	Kentucky	United States	40504
8	Research Site	Brighton	Massachusetts	United States	02135
9	Research Site	Greensboro	North Carolina	United States	27405
10	Research Site	Eugene	Oregon	United States	97401
11	Research Site	Altoona	Pennsylvania	United States	16602
12	Research Site	East Providence	Rhode Island	United States	02915
13	Research Site	Charleston	South Carolina	United States	29407
14	Research Site	Taylors	South Carolina	United States	29687
15	Research Site	Austin	Texas	United States	78758
16	Research Site	Dallas	Texas	United States	75231
17	Research Site	San Antonio	Texas	United States	78249
18	Research Site	Salt Lake City	Utah	United States	84107
19	Research Site	Henrico	Virginia	United States	23233
20	Research Site	Vancouver	British Columbia	Canada
21	Research Site	Smiths Falls	Ontario	Canada
22	Research Site	Toronto	Ontario	Canada

Sponsors and Collaborators

• ConjuChem

Investigators

• Study Director: Patrick Soon-Shiong, MD, Chief Executive Officer
• Principal Investigator: Robert Henry, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ConjuChem
• ClinicalTrials.gov Identifier: NCT01514149
• Other Study ID Numbers: DM200-103
• First Posted: Jan 20, 2012
• Last Update Posted: Jul 19, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by ConjuChem: Type 2 Diabetes Mellitus; T2DM; diabetes; ConjuChem; GLP-1; Glucagon-like peptide-1; exendin-4; modified exendin-4
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin

Study Results

Participant Flow

Arm/Group Title	Arm 1 - Weekly CJC-1134-PC	Arm 2 - Weekly CJC-1134-PC	Arm 3 - Weekly CJC-1134-PC	Arm 4 - Weekly CJC-1134-PC	Arm 5 - Weekly Placebo
Arm/Group Description	CJC-1134-PC, 1.5 mg. weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection	Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Period Title: Overall Study
STARTED	15	15	14	14	15
COMPLETED	12	14	11	13	14
NOT COMPLETED	3	1	3	1	1

Baseline Characteristics

Arm/Group Title	Arm 1 - Weekly CJC-1134-PC	Arm 2 - Weekly CJC-1134-PC	Arm 3 - Weekly CJC-1134-PC	Arm 4 - Weekly CJC-1134-PC	Arm 5 - Weekly Placebo	Total
Arm/Group Description	CJC-1134-PC, 1.5 mg. weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection	Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection	Total of all reporting groups
Overall Participants	15	15	14	14	15	73
Age, Customized (Count of Participants)
18 to 70 years	15 100%	15 100%	14 100%	14 100%	15 100%	73 100%
Sex: Female, Male (Count of Participants)
Female	6 40%	7 46.7%	6 42.9%	8 57.1%	4 26.7%	31 42.5%
Male	9 60%	8 53.3%	8 57.1%	6 42.9%	11 73.3%	42 57.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Time Frame	CFB to Week 18

Outcome Measure Data

Analysis Population Description

Completed Population

Arm/Group Title	Arm 1 - Weekly CJC-1134-PC	Arm 2 - Weekly CJC-1134-PC	Arm 3 - Weekly CJC-1134-PC	Arm 4 - Weekly CJC-1134-PC	Arm 5 - Weekly Placebo
Arm/Group Description	CJC-1134-PC, 1.5 mg. weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection	Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Measure Participants	12	14	11	13	14
Mean (Standard Deviation) [Percent (%)]	-0.56 (0.597)	-0.56 (0.627)	-0.95 (0.746)	-0.95 (0.828)	-0.13 (0.811)

2. Secondary Outcome

Title	Fasting Body Weight CFB to Week 18
Time Frame	CFB to Week 18

Outcome Measure Data

Analysis Population Description

Completed Population

Arm/Group Title	Arm 1 - Weekly CJC-1134-PC	Arm 2 - Weekly CJC-1134-PC	Arm 3 - Weekly CJC-1134-PC	Arm 4 - Weekly CJC-1134-PC	Arm 5 - Weekly Placebo
Arm/Group Description	CJC-1134-PC, 1.5 mg. weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection	Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Measure Participants	12	14	11	13	14
Mean (Standard Deviation) [kg]	-1.91 (1.624)	-0.14 (4.122)	-1.37 (2.182)	-0.92 (1.999)	-1.85 (4.083)

3. Secondary Outcome

Title	Time to Hyperglycemia Rescue
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

Completed Population

Arm/Group Title	Arm 1 - Weekly CJC-1134-PC	Arm 2 - Weekly CJC-1134-PC	Arm 3 - Weekly CJC-1134-PC	Arm 4 - Weekly CJC-1134-PC	Arm 5 - Weekly Placebo
Arm/Group Description	CJC-1134-PC, 1.5 mg. weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection	CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection	Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Measure Participants	12	14	11	13	14
Mean (Standard Deviation) [days]	NA (NA)	47.0 (53.74)	NA (NA)	NA (NA)	57.0 (NA)

Adverse Events

Time Frame	18 weeks
Arm/Group Title	Arm 1 - Weekly CJC-1134-PC		Arm 2 - Weekly CJC-1134-PC		Arm 3 - Weekly CJC-1134-PC		Arm 4 - Weekly CJC-1134-PC		Arm 5 - Weekly Placebo
Arm/Group Description	CJC-1134-PC, 1.5 mg. weekly subcutaneous injection		CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection		CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection		CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection		Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
All Cause Mortality
	Arm 1 - Weekly CJC-1134-PC		Arm 2 - Weekly CJC-1134-PC		Arm 3 - Weekly CJC-1134-PC		Arm 4 - Weekly CJC-1134-PC		Arm 5 - Weekly Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/15 (0%)		0/13 (0%)		0/13 (0%)		0/14 (0%)
Serious Adverse Events
	Arm 1 - Weekly CJC-1134-PC		Arm 2 - Weekly CJC-1134-PC		Arm 3 - Weekly CJC-1134-PC		Arm 4 - Weekly CJC-1134-PC		Arm 5 - Weekly Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/15 (0%)		0/13 (0%)		0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 - Weekly CJC-1134-PC		Arm 2 - Weekly CJC-1134-PC		Arm 3 - Weekly CJC-1134-PC		Arm 4 - Weekly CJC-1134-PC		Arm 5 - Weekly Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25%)		11/15 (73.3%)		8/13 (61.5%)		8/13 (61.5%)		5/14 (35.7%)
Gastrointestinal disorders
Nausea	1/12 (8.3%)		7/15 (46.7%)		5/13 (38.5%)		6/13 (46.2%)		1/14 (7.1%)
Vomiting	1/12 (8.3%)		2/15 (13.3%)		1/13 (7.7%)		5/13 (38.5%)		0/14 (0%)
Diarrhoea	0/12 (0%)		0/15 (0%)		1/13 (7.7%)		3/13 (23.1%)		2/14 (14.3%)
General disorders
Influenza like illness	1/12 (8.3%)		1/15 (6.7%)		0/13 (0%)		1/13 (7.7%)		0/14 (0%)
Infections and infestations
Upper respiratory tract infection	0/12 (0%)		2/15 (13.3%)		0/13 (0%)		0/13 (0%)		1/14 (7.1%)
Metabolism and nutrition disorders
Hypoglycemia	0/12 (0%)		1/15 (6.7%)		1/13 (7.7%)		1/13 (7.7%)		0/14 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/12 (0%)		1/15 (6.7%)		1/13 (7.7%)		1/13 (7.7%)		1/14 (7.1%)
Nervous system disorders
Headache	0/12 (0%)		2/15 (13.3%)		0/13 (0%)		1/13 (7.7%)		1/14 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.