Safety and Efficacy of Albiglutide in Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00849056

First received: February 19, 2009

Last updated: May 12, 2016

Last verified: May 2014

History of Changes

Results First Received: April 24, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Biological: albiglutide Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) who met eligibility criteria and completed a 4-week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 450 par. were screened; 310 par. were randomized, and 301 par. received >=1 treatment dose.

Reporting Groups

Description

Placebo + Pioglitazone With or Without Metformin

Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Albiglutide 30 mg + Pioglitazone With or Without Metformin

Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Participant Flow for 2 periods

Period 1: Treatment Period (TP) (156 Weeks)

	Placebo + Pioglitazone With or Without Metformin	Albiglutide 30 mg + Pioglitazone With or Without Metformin
STARTED	151	150
COMPLETED	88	100
NOT COMPLETED	63	50
Adverse Event	13	11
Protocol Violation	3	6
Noncompliance	3	3
Lost to Follow-up	7	5
Withdrawal by Subject	31	18
Physician Decision	3	3
Termination of Study/Site by GSK	1	4
Calcitonin Out of Range	1	0
Pregnancy	1	0

Period 2: Follow-up Period (FUP) (8 Weeks)

	Placebo + Pioglitazone With or Without Metformin	Albiglutide 30 mg + Pioglitazone With or Without Metformin
STARTED	149 ^[1]	149 ^[2]
COMPLETED	122	124
NOT COMPLETED	27	25
Adverse Event	1	3
Noncompliance	0	1
Lost to Follow-up	14	9
Withdrawal by Subject	9	7
Physician Decision	1	1
Termination of Study/Site by GSK	1	4
Early Termination	1	0

[1]	Par. withdrawing from the TP could enter the FUP. Two par. did not participate in the FUP.
[2]	Par. withdrawing from the TP could enter the FUP. One par. did not participate in the FUP.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Total	Total of all reporting groups

Baseline Measures

	Placebo + Pioglitazone With or Without Metformin	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Total
Number of Participants [units: participants]	151	150	301
Age [units: Years] Mean (Standard Deviation)	54.9 (9.40)	55.2 (9.98)	55.0 (9.67)
Gender [units: Participants]
Female	63	58	121
Male	88	92	180
Race/Ethnicity, Customized [units: Participants]
African American/African Heritage	20	19	39
American Indian or Alaskan Native	15	18	33
Asian - Central/South Asian Heritage	1	2	3
Asian - East Asian Heritage	2	3	5
Asian - Japanese Heritage	1	1	2
Asian - South East Asian Heritage	2	0	2
Native Hawaiian or other Pacific Islander	2	1	3
White - Arabic/North African Heritage	2	2	4
White - White/Caucasian/European Heritage	106	104	210

Outcome Measures

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1. Primary:

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 [ Time Frame: Baseline and Week 52 ]

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2. Secondary:

Change From Baseline in HbA1c at Weeks 104 and 156 [ Time Frame: Baseline and Weeks 104 and 156 ]

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3. Secondary:

Time to Hyperglycemia Rescue [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ]

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4. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: Baseline and Week 52 ]

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5. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 [ Time Frame: Baseline and Week 156 ]

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6. Secondary:

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 [ Time Frame: Week 52 ]

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7. Secondary:

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 [ Time Frame: Week 156 ]

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8. Secondary:

Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ]

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9. Secondary:

Change From Baseline in Body Weight at Week 156 [ Time Frame: Baseline and Week 156 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00849056 History of Changes
Other Study ID Numbers:	112755
Study First Received:	February 19, 2009
Results First Received:	April 24, 2014
Last Updated:	May 12, 2016
Health Authority:	United States: Food and Drug Administration

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