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This is an open label Phase II/III study to evaluate the efficacy and safety of test drug, Insulin Tregopil (IN-105) compared with Insulin Aspart (IAsp) in Type 2 Diabetes Mellitus patients. on stable dose of Metformin and insulin Glargine. The study will be conducted in 2 parts, Part I and Part II. The study duration will be approximately 37 weeks for Part I and for Part II of the study respectively
Part I of the study is a Phase II multi-center, randomized, open label clinical study to evaluate the efficacy and safety of Insulin Tregopil (2 dose levels: 30 mg, 45 mg) compared with IAsp in the treatment of T2DM patients. Part II of the study is the Phase III, multi-center, randomized, open label clinical study to evaluate the efficacy and safety of Insulin Tregopil (30 mg or 45 mg based upon the outcome of Part I data) compared with IAsp in the treatment of T2DM patients. For Part I and Part II, the study duration will be approximately 37 weeks (3 weeks Screening, 8 weeks Run-in, 24 weeks Treatment, 2 weeks Safety follow-up). An Independent Data and Safety Monitoring Board (DSMB) will evaluate the data from Part I of the study. Part II of the study will be initiated after approval from the office of Drugs Controller General of India (DCGI) and Data Safety Monitoring Board (DSMB) recommendation based on review of data from Part I of the study. In both Part I and Part II of the study, T2DM patients with glycated hemoglobin (HbA1c) 7.5 to 10% (both inclusive), on stable dose of metformin ± oral antidiabetic drugs (OADs) ± basal insulin who are eligible for insulin glargine administration as per investigator discretion and who satisfy the selection criteria will be enrolled. The eligible patients will go through a Run-in period of 8 weeks. At the end of 8 weeks Run-in period, eligibility will be checked and patients will enter the treatment period of 24 weeks and will be allocated to 3 treatment arms (Part I) or randomized to 2 treatment arms (Part II); if found eligible for randomization. A total of 90 patients in part 1 and 268 patients in part 2 will be randomised to the treatment arms from approximately 40 centers in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Tregopil (IN-105) - 45mg | Experimental | Strength of each tablet is 15mg |
|
| Insulin Tregopil (IN-105) - 30mg | Experimental | Strength of each tablet is 15mg |
|
| Insulin Aspart | Active Comparator | Pre-filled pen: 100 U/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Tregopil | Drug | Drug: Insulin Tregopil (IN-105) Mode of Administration: To be administered orally 10 ± 2 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at 24 Weeks (Part 1) | The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment. | Week 0, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 (Part 1) | This secondary outcome is the change from baseline in HbA1c after 12 weeks of randomized treatment. For this endpoint baseline (Week 0) and Week 12 have been presented. | Week 0, Week 12 |
| Participants Achieving HbA1c < 7% (Part 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24 | Number of participants achieving HbA1c < 7% at Week 12 and Week 24 without reported clinically significant or severe hypoglycemic events between end of Week 8 and Week 24. | Week 12, Week 24 |
Key Inclusion Criteria
Key Exclusion Criteria
Patients with T1DM
Treatment with glucagon-like peptide 1 agonists within 12 weeks prior to Screening
Ongoing treatment with OADs (eg, Thiazolidinediones) contraindicated or unapproved for combination treatment with insulin
Presence of gastrointestinal (GI) disorders or conditions known to significantly alter the absorption of orally administered drugs or significantly alter upper GI or pancreatic function
History of ≥2 episodes of severe hypoglycemia (as per ADA 2017) within the 6 months before Screening
History of > 1 episode of hyperglycemic hyperosmolar coma or hospitalization for uncontrolled diabetes (eg, diabetic ketoacidosis); within the 6 months prior to Screening
Clinically significant cardiovascular and/or cerebrovascular disease within 12 months before Screening including, but not limited to unstable angina, myocardial infarction, Class III or Class IV congestive heart failure according to the New York Heart Association criteria, valvular heart disease, cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack.
Patients with the following secondary complications of diabetes:
i. Active proliferative retinopathy as confirmed by a dilated ophthalmoscopy (by the investigator, site ophthalmologist or an optometrist; as per standard site practice) within 6 months prior to Screening. ii. Renal dysfunction indicated by modification of diet in renal disease estimated glomerular filtration rate < 45 mL/min/1.73 m2 and/or diabetic nephropathy and/or clinical nephrotic syndrome at Screening. iii. History or presence of severe form of neuropathy or signs and symptoms of severe cardiac autonomic neuropathy. iv. Patients with non-traumatic amputation (at any time) or clinically significant
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| Name | Affiliation | Role |
|---|---|---|
| Subramanian Loganathan, MD | Biocon Research Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diacon Hospital | Bangalore | Karnataka | 560010 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36352762 | Derived | Lebovitz HE, Fleming A, Cherrington AD, Joshi S, Athalye SN, Loganathan S, Vishweswaramurthy A, Panda J, Marwah A. Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study. Expert Opin Pharmacother. 2022 Nov;23(16):1855-1863. doi: 10.1080/14656566.2022.2141569. Epub 2022 Nov 9. |
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The trial included an 8-week run-in period and a 24-week treatment period. During the run-in period, the subjects received insulin glargine along with metformin. In total, 143 subjects entered the run-in period, of these 52 subjects were run-in failures. Hence, 91 subjects were randomly assigned to each treatment arm.
Out of 20 sites, which were selected for recruitment, 19 sites enrolled subjects in the run-in period, of which 15 sites later assigned subjects to randomized treatment: India:20 sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Tregopil (IN-105) - 45mg | At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. |
| FG001 | Insulin Tregopil (IN-105) - 30mg | SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. |
| FG002 | Insulin Aspart | At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set included all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Tregopil (IN-105) - 45mg | At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c at 24 Weeks (Part 1) | The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment. | The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects in Part 1. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation 'as randomized'. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | Week 0, Week 24 |
|
From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks.
Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Tregopil (IN-105) - 45mg | At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Subramanian L | Biocon Research limited | 080-28082808 | 1323 | subramanian.l101@biocon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2018 | Apr 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000615549 | Indium-105 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Study is conducted in two parts. Part I has 3 arms and Part 2 has 2 arms.
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Open Label Trial
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|
| Insulin Aspart | Drug | Drug: Insulin Aspart Mode of Administration: To be administered within 5 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit |
|
Number of participants achieving HbA1c < 7% at Week 12 and Week 24. |
| Week 12, Week 24 |
| Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1) | A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)] | Week 0 through Week 24 |
| Weight (Kgs) (Part 1) | Change from Baseline in weight (kgs) to 24 weeks | Week 0 and Week 24 |
| Lipid Profile (Part 1) | Change from Baseline in lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol) to 24 weeks | 24 weeks |
| Post-prandial Glucose (PPG) Excursion (Part 1) | Change from Baseline in the mean 60, 90, 120 minutes PPG excursions assessed from standardized test meal at Week 24. | Week 0, Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (Part 1) | Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks | 24 weeks |
| Anti-drug Antibody Levels | Incidence and change from baseline in the relative levels of anti-drug antibody levels over 24 weeks | 24 weeks |
| CGM | Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study | 24 weeks |
| Voluntary withdrawal of consent |
|
| BG001 | Insulin Tregopil (IN-105) - 30mg | At randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. |
| BG002 | Insulin Aspart | At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. |
| BG003 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Duration of T2DM | Mean | Standard Deviation | years |
|
| Glycosylated haemoglobin A1c | Mean | Standard Deviation | Percentage of glycosylated haemoglobin |
|
| OAD/Basal Insulin use at Screening Number of participants (%) | Count of Participants | Participants |
|
| Metformin dose Number of participants (%) | Number | participants |
|
| Other Abnormalities, Yes or No | Number | participants |
|
| Active proliferative retinopathy, Yes or No | Number | participants |
|
| OAD use evaluated at screening | Number | participants |
|
| OG001 |
| Insulin Tregopil (IN-105) - 30mg |
Strength of each tablet is 15mg Insulin Tregopil: Drug: Insulin Tregopil (IN-105) Mode of Administration: To be administered orally 10 ± 2 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit. |
| OG002 | Insulin Aspart | Pre-filled pen: 100 U/L Insulin Aspart: Drug: Insulin Aspart Mode of Administration: To be administered within 5 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit |
|
|
|
| Secondary | Change From Baseline in HbA1c at Week 12 (Part 1) | This secondary outcome is the change from baseline in HbA1c after 12 weeks of randomized treatment. For this endpoint baseline (Week 0) and Week 12 have been presented. | This endpoint was summarized using ITT analysis set in Part I. ITT set included all randomized subjects. At Week 12, data from available participants are summarized. | Posted | Mean | Standard Deviation | Percentage of glycosylated haemoglobin | Week 0, Week 12 |
|
|
|
| Secondary | Participants Achieving HbA1c < 7% (Part 1) | Number of participants achieving HbA1c < 7% at Week 12 and Week 24. | This endpoint was summarized using intention-to-treat (ITT) analysis set. ITT set included all randomized participants. At Week 12 and Week 24, data from available participants are summarized. | Posted | Count of Participants | Participants | Week 12, Week 24 |
|
|
|
| Secondary | Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1) | A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)] | This endpoint was summarized using safety analysis set in Part I. Safety analysis set included patients who were randomized and took at least 1 dose of the study drug. Patients in the safety analysis set contributed to the evaluation 'as treated'. | Posted | Count of Participants | Participants | Week 0 through Week 24 |
|
|
|
| Secondary | Weight (Kgs) (Part 1) | Change from Baseline in weight (kgs) to 24 weeks | This endpoint was summarized using completed participants at Week 24 and all randomised participants at Week 0 in Part I. Change from baseline was summarised using completed participants. | Posted | Mean | Standard Deviation | Kg | Week 0 and Week 24 |
|
|
|
| Secondary | Lipid Profile (Part 1) | Change from Baseline in lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol) to 24 weeks | This was planned for part 2 of the study. As part-2 of the study was discontinued, this is not applicable. | Posted | 24 weeks |
|
|
| Secondary | Post-prandial Glucose (PPG) Excursion (Part 1) | Change from Baseline in the mean 60, 90, 120 minutes PPG excursions assessed from standardized test meal at Week 24. | This endpoint was summarized using the intention-to-treat (ITT) analysis set from Part I. ITT set included all randomized participants. At Week 24, data from available participants are summarized. | Posted | Mean | Standard Deviation | mg/dL | Week 0, Week 24 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (Part 1) | Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks | This endpoint was summarized using Treatment Emergent Adverse Events - Safety Analysis Set (Part I). | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Anti-drug Antibody Levels | Incidence and change from baseline in the relative levels of anti-drug antibody levels over 24 weeks | This was planned for part 2 of the study. As part-2 of the study was discontinued, this is not applicable. | Posted | 24 weeks |
|
|
| Secondary | CGM | Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study | This was planned for part 2 of the study. As part-2 of the study was discontinued, this is not applicable. | Posted | 24 weeks |
|
|
| Other Pre-specified | Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24 | Number of participants achieving HbA1c < 7% at Week 12 and Week 24 without reported clinically significant or severe hypoglycemic events between end of Week 8 and Week 24. | This endpoint was summarized using intention-to-treat (ITT) analysis set in Part I. ITT set included all randomized participants. At Week 12 and Week 24, data from available participant are summarized. | Posted | Count of Participants | Participants | Week 12, Week 24 |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 5 |
| 31 |
| EG001 | Insulin Tregopil (IN-105) - 30mg | SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. | 0 | 30 | 0 | 30 | 5 | 30 |
| EG002 | Insulin Aspart | At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose | 0 | 30 | 0 | 30 | 4 | 30 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Dysentery | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection viral | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vulval laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Lethargy | Nervous system disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Vascular disorders | Renal and urinary disorders | Systematic Assessment |
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| Hypertension | Renal and urinary disorders | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Week 12 |
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| Change from Baseline |
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| Week 24 |
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| Week24 |
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| Change from Baseline |
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| Week 0, 90 min |
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| Week 0, 120 min |
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| Week 24, 60 min |
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| Week 24, 90 min |
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| Week 24, 120 min |
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| Week 24 |
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