Diabetes Mellitus, Type 2Phase 2NCT00747006

Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

A Phase 2 study testing TI Inhalation Powder and Humalog (Amendment 1) and TI Inhalation Powder (original protocol) in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Mannkind Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What is being tested?: TI Inhalation Powder and Humalog (Amendment 1) and TI Inhalation Powder (original protocol)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Sep 2008to May 2011
Phase: Phase 2
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnoses of type 1 or type 2 diabetes mellitus
Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) > 6.5% and < or = 10.0%.
Body mass index (BMI) of < or = 40 kg/m2
Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dL
Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%
For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment

Who cannot join

History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
Elevated liver function test (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
Exposure to any investigational product(s) in the past 12 weeks
For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects

Trial locations and contacts

1 site in 1 country.

United States1 site

Sansum Medical Research Institute
Santa Barbara, California, 93105

Other trials in United States

About this study

Official title: A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content

The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.

Conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Being tested: TI Inhalation Powder and Humalog (Amendment 1), TI Inhalation Powder (original protocol)
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

What participants receive

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

TI Inhalation Powder and Humalog (Amendment 1)Drug
Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.
TI Inhalation Powder (original protocol)Drug
Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics

Study groups in NCT00747006
Study group	Role	What they receive
TI Inhalation Powder (original protocol)	Experimental	Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits. Receives: Drug: TI Inhalation Powder (original protocol)
TI Inhalation Powder and Humalog (Amendment 1)	Other	Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents). Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents). Subjects will also use TI Inhalation Powder daily at each meal between visits. Receives: Drug: TI Inhalation Powder and Humalog (Amendment 1)

What is being measured

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

Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC
Measured: 0 to 240 minutes
Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC
Measured: 0 to 240 minutes
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC
Measured: 0 to 240 minutes
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.
AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.
TIme 0 corrected AUC (0-240) = AUC - AOC
Measured: 0 to 240 minutes
Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
Measured: 0 to 240 minutes
Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
Measured: 0 to 240 minutes
Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Measured: 0 to 240 minutes
Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Measured: 0 to 240 minutes

Secondary outcomes (4)

Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
Measured: 0 to 240 minutes
Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast
Measured: 0 to 240 minutes
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Measured: 0 to 240 minutes
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Measured: 0 to 240 minutes

Timeline

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

Sep 2008May 2011

First posted4 Sep 2008 (estimated)
Study startSep 2008
Primary completionFeb 2011
Study completionMay 2011

Why it stopped: Business reasons

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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00747006
Sponsor's protocol ID: MKC-TI-119
Status last verified: Oct 2014
First submitted: 3 Sep 2008
Last updated: 30 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

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 Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content
ClinicalTrials.gov ID: NCT00747006
Acronym / sponsor ID: MKC-TI-119
Conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business reasons
Enrolment: 18 participants (actual)
Lead sponsor: Mannkind CorporationIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Feb 2011 (actual)
Study completion: May 2011 (actual)
First posted: 4 Sep 2008 (estimated)
Results: Posted 21 Oct 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TI Inhalation Powder (original protocol)	Experimental	Drug: TI Inhalation Powder (original protocol)Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits.
TI Inhalation Powder and Humalog (Amendment 1)	Other	Drug: TI Inhalation Powder and Humalog (Amendment 1)Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents). Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents). Subjects will also use TI Inhalation Powder daily at each meal between visits.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Clinical diagnoses of type 1 or type 2 diabetes mellitus
Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) > 6.5% and < or = 10.0%.
Body mass index (BMI) of < or = 40 kg/m2
Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dL
Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%

Key exclusion criteria (6 listed)

History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
Elevated liver function test (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
Exposure to any investigational product(s) in the past 12 weeks

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
TI Inhalation Powder and Humalog (Amendment 1)Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.	Drug	TI Inhalation Powder and Humalog (Amendment 1)
TI Inhalation Powder (original protocol)Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics	Drug	TI Inhalation Powder (original protocol)

Primary outcome

Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time frame: 0 to 240 minutes
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time frame: 0 to 240 minutes
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Time frame: 0 to 240 minutes
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Time frame: 0 to 240 minutes
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
Time frame: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Time frame: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
Time frame: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
Time frame: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch

4 secondary outcomes

Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time frame: 0 to 240 minutes
Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time frame: 0 to 240 minutes
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Time frame: 0 to 240 minutes
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Time frame: 0 to 240 minutes

Results and safety

Results posted to the registry on 21 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Original Protocol Type 1 Diabetes	7	4
Original Protocol Type 2 Diabetes	8	7
Amendment 1 Type 2 Diabetes	3	2

Primary outcome: Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)

Time frame: 0 to 240 minutes. Mean (Full Range). Unit: min*mg/dL

Measure	100% Carbohydrate Load n = 2	0% Carbohydrate Load n = 0	50% Carbohydrate Load n = 0	150% Carbohydrate Load n = 3	200% Carbohydrate Load n = 3
Value	-41.44 (-43.44 to -39.43)	–	–	251.65 (24.08 to 490.63)	454.07 (329.64 to 636.50)

Population analysed: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI

Primary outcome: Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)

Time frame: 0 to 240 minutes. Mean (Full Range). Unit: min*mg/dL

Measure	100% Carbohydrate Load n = 2	0% Carbohydrate Load n = 0	50% Carbohydrate Load n = 3	150% Carbohydrate Load n = 2	200% Carbohydrate Load n = 3
Value	104.32 (14.50 to 194.13)	–	10.80 (-44.86 to 98.50)	199.35 (116.70 to 282.00)	440.90 (269.18 to 583.13)

Population analysed: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI

Primary outcome: Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)

Time frame: 0 to 240 minutes. Mean (Full Range). Unit: min*mg/dL

Measure	100% Carbohydrate Load n = 2	0% Carbohydrate Load n = 2	50% Carbohydrate Load n = 1	150% Carbohydrate Load n = 0	200% Carbohydrate Load n = 2
Value	-6.11 (-22.63 to 10.41)	-74.26 (-99.88 to -48.63)	-22.80 (-22.80 to -22.80)	–	11.56 (-2.36 to 25.47)

Population analysed: Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Primary outcome: Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)

Time frame: 0 to 240 minutes. Mean (Full Range). Unit: min*mg/dL

Measure	100% Carbohydrate Load n = 2	0% Carbohydrate Load n = 2	50% Carbohydrate Load n = 2	150% Carbohydrate Load n = 0	200% Carbohydrate Load n = 2
Value	15.77 (9.48 to 22.06)	-51.26 (-89.13 to -13.38)	4.18 (-15.39 to 23.75)	–	-8.15 (-68.76 to 52.47)

Population analysed: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TI Original Protocol Type 1 DM	0 of 7 (0%)	7 of 7 (100%)	Not reported
TI Original Protocol Type 2 DM	3 of 8 (37.5%)	7 of 8 (87.5%)	Not reported
TI Amendment 1 Type 2 DM	0 of 3 (0%)	3 of 3 (100%)	Not reported
Humalog Amendment 1 Type 2 DM	0 of 2 (0%)	1 of 2 (50%)	Not reported

Limitations and caveats (from the sponsor): \- Early termination of trial leading to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 2

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.

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Oct 2014). 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?

Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects) (time frame: 0 to 240 minutes). The study lists 8 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 NCT00747006.

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 30 Oct 2014.