Type 2 Diabetes MellitusPhase 3NCT01406717

Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing SPIL1033 in people with Type 2 Diabetes Mellitus, run by Sun Pharmaceutical Industries Limited at 34 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033 Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: SPIL1033
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 34 sitesIndia
Study dates: 1 Mar 2013to 4 Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects 20 years of age and older.
Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
Weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit.
Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test.
Willing to participate and give written informed consent.

Who cannot join

Previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (GLP-1) analogue.
Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening.
Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry.
Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

India34 sites

SPIL Site 1
Ahmedabad, Gujarat
SPIL Site 2
Ahmedabad, Gujarat
SPIL Site 3
Ahmedabad, Gujarat
SPIL Site 19
Bangalore, Karnataka
SPIL Site 30
Bangalore, Karnataka
SPIL Site 31
Bangalore, Karnataka
SPIL Site 33
Bangalore, Karnataka
SPIL Site 13
Bhubaneswar, Orrissa
SPIL Site 16
Chennai, Tamil Nadu
SPIL Site 17
Coimbatore, Tamil Nadu
SPIL Site 20
Coimbatore, Tamil Nadu
SPIL Site 22
Hyderabad, Andhra Pradesh
SPIL Site 25
Hyderabad, Andhra Pradesh
SPIL Site 26
Hyderabad, Andhra Pradesh
SPIL Site 35
Indore, Madhya Pradesh
SPIL Site 14
Jaipur, Rajasthan
SPIL Site 15
Jaipur, Rajasthan
SPIL Site 27
Lucknow, Uttar Pradesh
SPIL Site 28
Lucknow, Uttar Pradesh
SPIL Site 18
Madurai, Tamil Nadu, 625020
SPIL Site 29
Manipal, Karnataka
SPIL Site 21
Nagpur, Maharashtra
SPIL Site 24
Nagpur, Maharashtra
SPIL Site 32
Nashik, Maharashtra
SPIL Site 11
Pune, Maharashtra
SPIL Site 12
Pune, Maharashtra
SPIL Site 5
Rajkot, Gujarat
SPIL Site 6
Surat, Gujarat
SPIL Site 7
Surat, Gujarat
SPIL Site 8
Surat, Gujarat
SPIL Site 9
Surat, Gujarat
SPIL Site 10
Vadodara, Gujarat
SPIL Site 34
Vellore, Tamil Nadu
SPIL Site 23
Visakhapatnam, Andhra Pradesh

Other trials in India

About this study

SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033

Read the detailed description

SPIL1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus.

In this study, efficacy and safety of SPIL1033 will be evaluated. Subjects will receive SPIL1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: SPIL1033, Placebo
Keywords: SPIL1033, type 2 diabetes mellitus
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPIL1033Drug
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
PlaceboDrug
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Study groups in NCT01406717
Study group	Role	What they receive
SPIL1033	Experimental	Not described Receives: Drug: SPIL1033
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
Measured: 24 weeks
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
Measured: 24 weeks
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
Measured: 24 weeks
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
Measured: 24 weeks

Secondary outcomes (8)

Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
Measured: 24 weeks
Change From Baseline in Triglycerides
Measured: 24 weeks
Change From Baseline in Low Density Lipoproteins
Measured: 24 weeks
Change From Baseline in High Density Lipoproteins
Measured: 24 weeks
Change in Body Weight
Measured: 24 weeks
Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
Measured: 24 weeks
Change From Baseline in Very Low Density Lipoproteins
Measured: 24 weeks
Change From Baseline in Total Cholesterol
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20134 Nov 2015

First posted1 Aug 2011 (estimated)
Study start1 Mar 2013
Primary completion4 Nov 2015
Study completion4 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01406717
Sponsor's protocol ID: CLR_10_33
Status last verified: Jul 2020
First submitted: 28 Jul 2011
Last updated: 11 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01406717
Acronym / sponsor ID: CLR_10_33
Conditions: Type 2 Diabetes Mellitus
Keywords: SPIL1033, type 2 diabetes mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: 1 Mar 2013
Primary completion: 4 Nov 2015 (actual)
Study completion: 4 Nov 2015 (actual)
First posted: 1 Aug 2011 (estimated)
Results: Posted 1 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033

Detailed description

SPIL1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus.

In this study, efficacy and safety of SPIL1033 will be evaluated. Subjects will receive SPIL1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SPIL1033	Experimental	Drug: SPIL1033
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female subjects 20 years of age and older.
Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
Weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit.
Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test.
Willing to participate and give written informed consent.

Key exclusion criteria (4 listed)

Previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (GLP-1) analogue.
Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening.
Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry.
Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPIL10335 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.	Drug	SPIL1033
Placebo5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.	Drug	Placebo

Primary outcome

Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
Time frame: 24 weeks
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
Time frame: 24 weeks
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
Time frame: 24 weeks
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
Time frame: 24 weeks

8 secondary outcomes

Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
Time frame: 24 weeks
Change From Baseline in Triglycerides
Time frame: 24 weeks
Change From Baseline in Low Density Lipoproteins
Time frame: 24 weeks
Change From Baseline in High Density Lipoproteins
Time frame: 24 weeks
Change in Body Weight
Time frame: 24 weeks
Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
Time frame: 24 weeks
Change From Baseline in Very Low Density Lipoproteins
Time frame: 24 weeks
Change From Baseline in Total Cholesterol
Time frame: 24 weeks

Results and safety

Results posted to the registry on 1 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPIL1033	180	137
Placebo	180	149

Primary outcome: Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: percentage of hemoglobin A1c (HbA1c)

Measure	SPIL1033 n = 112	Placebo n = 94
Value	-0.227 (0.243)	-0.227 (0.254)

SPIL1033 vs Placebo: ANCOVA: 0.0002 (95% CI -0.31377 to 0.31418)

Population analysed: Intent-to-treat

Primary outcome: Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: mg/dL

Measure	SPIL1033 n = 110	Placebo n = 94
Value	0.48 (9.78)	-5.42 (10.21)

SPIL1033 vs Placebo: ANCOVA: 5.898 (95% CI -6.7565 to 18.5535)

Primary outcome: Count and Percentage of Subjects Positive for Anti-exenatide Antibodies

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	SPIL1033 n = 133	Placebo n = 143
Value	59	2

SPIL1033 vs Placebo: p <0.0001, Mantel Haenszel

Population analysed: modified intent to treat population

Primary outcome: Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	SPIL1033 n = 179	Placebo n = 178
Value	3	3

Population analysed: Evaluable population for safety: subjects who were randomized and received at least one dose of a trial medication

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPIL1033	6 of 180 (3.3%)	126 of 180 (70%)	0 of 180
Placebo	1 of 180 (0.6%)	115 of 180 (63.9%)	0 of 180

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPIL1033 in people with Type 2 Diabetes Mellitus, run by Sun Pharmaceutical Industries Limited at 34 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to End of Study in Hemoglobin A1c (HbA1c) (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01406717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.